7-3 BLR 9490 Cartridge Packaging Validation

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Title: Reusable Injector Cartridge Ship Test
I Revision:
Document Number: BLR9490
I Page 1 of 63
AUSCH
LOMB
Global Packaging Engineering

Rochester, NV
Reusable Injector Cartridge

Ship Test Report
BLR9490
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Prep ared By: __
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Troy Painton
Sr. Packaging Engineer
Approval Signatures I Dates
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Project Manager: Sushant Muchhala

Global Packaging Manager: Brian Buxton (
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D&R Engineering: Will Sea

Global Regulatory Affairs: Jason Smith
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EMO: Randy Woods
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Global Quality: Sanaz Sotodeh
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Supplier Quality: Joe Melnick
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Medicel: Tobias Maier
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CONFIDENTIAL
G/t 3/13
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Reuuble Injector Cartridge Ship Test
Revision: A
AUSCH
OM

Rochester, NY

Ship Test Report
BLR9490
Prepared By:
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Approval Signatures
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Project Manager: Sushant Muchhal
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Global Packaging Manager: Brian Buxton
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D&R Engineering: Will Seo

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EMO: Randy Woods
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Rochester, NY

Ship Test Report
BLR9490
Prepared By:
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EMO: Randy
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Global Quality: Sanaz
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Date:
Date:
CONFIDENTIAL
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Revision: A
Document Number: BLA9490
Page1 of 63
BAUSC

Rochester, NV

Ship Test Report
BLR9490
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Prepared By: __
Troy Polnton
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Medicel: Tobias Maler
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CONFIDENTIAL
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I Page 2 of 63
Table of Contents
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
EXECUTIVE SUMMARY
INTRODUCTION
PURPOSE
SCOPE
DEFINITIONS, ACRONYMS, AND ABBREVIATIONS
REFERENCES
RESPONSIBILITIES
PRE-REQUISITES AND GENERAL REQUIREMENTS
SAMPLING PLAN AND RATIONALE
TEST SAMPLE PREPARATION
TEST PROCEDURE
POST SHIP TEST INSPECTION
PRODUCTION DISPOSITION
DEVIATIONS TO THE PROTOCOL
SUMMARY
ATTACHMENTS
CONFIDENTIAL
4
4
4
4
4
5
5
5
6
6
6
9
11
11
11
11
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REVISION HISTORY
Revision
No.
Revision History
Original Document
CONFIDENTIAL
Author
Date
T. Painton
6/12/2013
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Revision: A
Page 4 of 63
EXECUTIVE SUMMARY
This report documents the proposed packaging configuration for the AX-Xl reusable injector cartridges
for Project ROSOl ability to withstand the anticipated distribution hazards.
One deviation occurred during functional lens delivery. Functional lens delivery was re-executed,
according to DFU procedures, and acceptance criteria were met. See Deviation Form in Attachment 5
for additional details.
This transportation test documents evidence the reusable injector cartridge packaging configuration
protects the product when exposed to the hazards of normal handling, storage and distribution per
ISTA 3A standard and the product delivers lenses as intended. This transportation test provides
documented evidence of compliance with applicable IS0-11607-1:2009 requirements. Therefore, the
reusable injector cartridge packaging configuration has met all acceptance criteria.
2.0
INTRODUCTION
This report documents the proposed packaging configuration for the AX-Xl reusable injector cartridges
for Project ROSOl ability to withstand the anticipated distribution hazards.
3.0
PURPOSE
This transportation test provides documented evidence the reusable injector cartridge packaging
configuration protects the product when exposed to the hazards of normal handling, storage and
distribution per ISTA 3A standard.
This transportation test provides documented evidence of compliance with applicable IS0-116071:2009 requirements.
4.0
SCOPE
This verification is limited to the AX-Xl reusable injector cartridges being developed under B&L Project
ROSOl. Cartridges are manufactured and packaged at Medicel.
5.0
Name
AVC
B&L
oc
DDL
ISTA
N/A
No. or#
P/N
PC
Description
Bausch & Lomb Aliso Viejo, CA
Bausch and Lomb
Celsius (in degrees)
Distribution Dynamic Labs
International Safe Transit Association
Not Applicable
Number
Part Number
Procedural Choice
CONFIDENTIAL
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Name
RH
SOP
%
6.0
Description
Relative Humidity
Standard Operational Procedure
Percent
REFERENCES
Document Title
Document #/Rev
Detecting Gross Leaks in Packaging by Internal Pressurization

(Bubble Test)
Medicel control card for Building Axiom IOL Delivery System Xl
Cartridge
Cartridge
Packaged-Products for Parcel Delivery System Shipment 70kg
(150lb) or less
enVista MX60 IOL
Ophthalmic implants-- Intraocular lenses
ASTM F2096-11
Viscoject 1.8 Cartridge
Set instructions, Rev. 00
ISTA 3A-2008
FP-3244, Rev F
ISO 11979-5:2006
7.0
RESPONSIBILITIES
Group
B&L Global Packaging
Medicel
B&L AVC
DOL -Testing
Laboratory
8.0
Page 5 of 63
Revision: A
Responsibilities
Wrote the protocol and final summary report

Arranged for testing at the ship test facility
Test sample builds
Functional Lens Delivery
Subjected test samples to the conditioning and test parameters
Returned test samples to B&L Aliso Viejo, CA

Training- Current Good Manufacturing Practices for Medical devices were followed throughout the
execution of the protocol. Operators were trained and training is documented in Attachment 2.
Process Equipment- No new computer systems or processing equipment were implemented that
would require validation before the procedures executed. Measurement equipment was appropriate
for the attributes being measured and capable of providing meaningful and valid results.
Process Materials/Components- Materials and packaging components for this study were inspected,
approved and released for use prior to any testing.
CONFIDENTIAL
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Revision: A

Sample size of six (6) cartons, sixty (60) cartridges in total, were used to for this testing. Hot and cold
environmental conditioning was conducted on three (3) carton test samples at each condition.
Functional lens delivery testing was included as part of the acceptance criteria. Ten lenses were
delivered for each environmental condition parameter to satisfy the minimum requirements of ISO
11979:2006. enVista MX60 lenses with various diopters were used for functional lenses delivery. AX-R1
Handpieces from BLP9489 were used for lens delivery. Handpiece serial numbers were recorded in the
lens delivery datasheets. Lenses delivery was captured in BLP9489 datasheets and is included in
Attachment 6.
10.0

The following procedures were followed for protocol execution:
10.1 Built and packaged sixty (60) cartridges per Medicel control card Viscoject 1.8 and 2.2
Cartridge Set instructions for Axiom IOL Delivery System X1 Cartridge
10.2 Placed packaged cartridge samples into over shipper. Labeled outside of shipper with
BLP9490.
10.3 Shipped test samples to test facility at the address below via expedited air I truck shipment:
DDL, Inc.
10200 Valley View Road, Suite #101
Eden Prairie, MN 55344
11.0
TEST PROCEDURE
The following procedures were followed for protocol execution :
11.1
Upon receipt of test sample at the test facility, the test samples were removed from its overpackaging and subjected to each of the following environmental conditions for no less than 72
hours.
#of Cartons
Test Condition
Cold
Hot
Temperature I RH
Duration
-10C 5 I Uncontrolled Relative

Humidity
+50C 5 I 85% 5 Relative Humidity
Then
72 hours
48 hours
24 hours
The total time exposed is included in the report from test laboratory. Report in Attachment 3.
CONFIDENTIAL
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11.2
Identification of test sample faces, corners, and edges:
11.3
Drop Sequence: 9 drops were performed per ISTA 3A as indicated in the following:
11.4
Random Vibration: Random vibration will be completed per ISTA 3A as indicated in the
following:
NOTE: No top load weight is required based on the top load calculations are less than 2Sibs.
CONFIDENTIAL
10
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I Revision:
Frequency
(It;:)
PSD Level,
gl/Hz
10
30
50
7.0
0.0007
002
0.02
0.001
12.0
150
0.001
0004
24.0
280
360
420
750
200 0
0.004
0001
0001
0003
0.003
0.000004
I Page 8 of 63
1STA3 A. 0 ver-the-Road Trailer s l)ectrum
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001
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0.001
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0 0001
0.00001
_l
0 000001
...............
I
Ill
100
10
Frequency, Hz.
11.5
Random Vibration: Random vibration was completed per ISTA 3A as indicated in the following :
ISTA 3A - Pick-up and Delivery Vehicle Spectrum
Frt qJt ncy
(Hz)
1.0
.0
.0
i .O
H.O
1;.0
2t.O
PSDLevlll,
g2niz
23.0
0.0001
5).0
0.0001
0.002
0.002
0.00005
n .o
1(0.0
2~0.0
--+----
-+- --
0.001
0.035
0.035
. 0 03
0.0003
0.001
0.001
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10
100
Frequency, Hz.
11.6
Drop Sequence: 8 drops were performed per ISTA 3A as indicated in the following:
CONFIDENTIAL
11
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Title: Reusable .Injector Cartridge Ship Test
11.7
Revision: A
Page 9 of 63
Upon completion of the ISTA 3A procedure, one(1) carton from each environmental
conditioning group was overnight delivered to B&L:
Attention: Sushant Muchhala
Bausch+ Lomb
30 Enterprise, Suite 450
Aliso Viejo, CA 92656
Remaining 2 cartons from each environmental conditioning group were bubble leak tested per
ASTM F2096-11.
12.0

12.1
The following evaluations were executed post ship testing at B&L Aliso Viejo:
Product Inspection: Evaluate 10 cartridges (1 carton) from each temperature

condition. Visually inspect carton label legibility, carton, DFU, and sealed cartridge
packaging for damage under normal office lighting conditions.
Acceptance Criteria
Carton label must be legible. Carton, DFU, and handpiece must not have any excessive
damage when viewed under normal office lighting conditions.
Results
Visually inspected 10 cartridges, from each temperature condition, for carton label
legibility. Visually inspected 10 cartridges, from each temperature condition, carton,
DFU, and handpiece for damage under normal office lighting conditions. All
acceptance criteria were met. Documented the results in Attachment 4 datasheets.
CONFIDENTIAL
12
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Functional Lens Delivery: Following product inspection deliver 10 lenses, one per
cartridge, from each temperature condition. Verify dimensional acceptance per the
following:
Finished Product
Specification
Drawing Number
Spherical Power Range
FP-3244
BL000024661, Rev. A
BL000024653, Rev. A
O.OD to +4.0D
+10.0D to +34.0D
Results were documented in Attachment 5.

Acceptance Criteria
All lenses must meet dimensional acceptance per the following :
Finished Product
Specification
Drawing Number
FP-3244
BL000024661, Rev A
BL000024653, Rev A
O.OD to +4.0D
+10.0D to +34.0D
Results
Delivered 10 lenses, two per handpiece, from each temperature condition . Verified
dimensional acceptance per the following:
Finished Product
Specification
Drawing Number
FP-3244
BL000024661, Rev A
BL000024653, Rev A
O.OD to +4.0D
+10.0D to +34.0D
All acceptance criteria were met. Documented results in Attachment 5 datasheet.

12.2
The following evaluations will be executed post ship testing at DDL:

Bubble Leak: Evaluate 20 cartridge trays (2 cartons) from each temperature condition.
Perform bubble leak testing per ASTM F2096-11. Verify no leaks occur. Document the
results in Attachment 6 datasheets.
Acceptance Criteria
Verify no leaks occur
CONFIDENTIAL
13
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Results
Perform bubble leak testing per ASTM F2096-11. No leaks occur. All acceptance
criteria were met. Documented results in Attachment 6 datasheets.
13.0
PRODUCT DISPOSITION
The protocol manager will disposition all package samples produced and used for the purposes of this
study within three months after the summary report is completed and approved.
Product utilized for this study is for experimental purposes only and not for commercial use.
14.0
One deviation occurred during functional lens delivery. During the functional lens delivery section of
the 'Post Ship Test Inspection', plunger tip override was observed on lens sample #35 (serial number:
3217315002). The plunger tip rode on top of the lens optic approximately 0.5 to 1.0 mm but was able
to advance and exit the lens from the inserter with the plunger tip over the lens optic. However per
the DFU, the user is to ensure that the plunger remains behind the lens until the lens fully exits the
inserter tip.
Due to lens #35 (serial number: 3217315002) not remaining in front of the plunger tip during lens
delivery, the sample was not used as part ofthe functional delivery testing data and was replaced with
lens serial number 3350608019 and retested. The operator ensured that the plunger tip remained
behind the lens during the delivery and the post-cosmetic delivery acceptance criteria were met.
15.0
SUMMARY
This transportation test documents evidence the reusable injector cartridge packaging configuration
protects the product when exposed to the hazards of normal handling, storage and distribution per
ISTA 3A standard and the product delivers lenses as intended. This transportation test provides
documented evidence of compliance with applicable IS0-11607-1:2009 requirements. Therefore, the
reusable injector cartridge packaging configuration has met all acceptance criteria.
16.0
ATTACHMENTS
Attachment 1- Ship Test Plan

Attachment 2- Training Record
Attachment 3 - DDL Report
Attachment 4- Visual Inspection
Attachment 5- Lens Delivery
Attachment 6- Bubble Leak
CONFIDENTIAL
14
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Page 12 of 63
Sample Preparation
Medicel built test samples
!
Ship Testing
Environmental conditioning, vibration, and drop testing
were be conducted at DDL packaging test lab
Bubble Leak Testing

Bubble leak tested at
DDL packaging test lab
!
Test Sample Inspection
Visual inspection and functional lens delivery at
~
Generate Report
Global Packaging generated a report
CONFIDENTIAL
15
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CONFIDENTIAL
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Revision: A
Document Number: BLP9490
Page 11 of 15
Attachment 1 -Training Record
BAUSCH
LO
Training Record
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BLP9490
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Training Verification:
Date:
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Revision: A
18.1.2-GFORM-14
CONFIDENTIAL
17
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Attachment 1 - Training Record
BAUSCH
Training Record
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Revision : A
18.1.2-GFORM-14
CONFIDENTIAL
18
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I Page 16 of 63
Attachment 3- DDL Report
CONFIDENTIAL
19
Transportation Simulation Testing

for the
Bausch & Lomb

Reusable Injector Handpiece Ship Test & Reusable Injector
Cartridge
Report Number: R1304158-01-00
Bausch & Lomb Protocol Numbers: BLP9489 Rev. A and BLP9490, Rev. A
PO Number: Credit Card Payment
11June2013
Client: Bausch & Lomb

Contact: Troy Painton
1400 N Goodman Street
Rochester, NY 14609
Test Performed by:
DDL
Tested and proven.
DOL, "W.o:r
17371 Mt. Wynne Circle, Suite A
Fountain Valley, CA 92708
tel : 714.979.1712 1800.229.4235
fax: 714.979.1721
DOL, ?......
10200 Valley View Road, Suite 101
tel: 952.941.9226 1800.229.4235
fax: 952.941.9318
www.testedandproven.com
CONFIDENTIAL
20
TABLE OF CONTENTS
Revision Record .................................................................................................. 2
Introduction .........................................................................................................2
Objective ... ......... ....... ........................................ .................................... ....... ... ..... .... ... ..... ... ... ... . 2
Scope ............. ...... ............... ................ ........ .. .. ....... ......... ........ ....... ... .... .... .. ........ ..... ............ ...... 2
Summary of Tested Specimens ......................................................................... 2

Packaging System ..............................................................................................3
Protective Package ............................................. ........................................... .... ........................ 3
Shipping Unit ..... ............ ........... ....... ............................................... ...... ..... .. .... .................... 3
Sterile Barrier System .......... .......... .......... ... ..... ... ... .... .................... .... ... ..... .... .............. .............. 3
Product ................................................................................................................4
Results Summary ................................................................................................4
Acceptance Criteria .. ..... .... ..... ..... .. ... .... ........ ... .. ..... ... ... .. ......... ... ... .. .......... .. .. ...... ... ... ........ ... ... .. 4
Environmental Conditioning ................. ....... .. .. .. ........ .. ..... ...... ......... .. .. .... .. ..... ..... ...... ...... ... ..... ... 4
Distribution Simulation Testing ........... ........................... .. ...... ...... ....... .................... ........ ... ........ 4
Package Integrity Testing ................................ .... ... ... .. .. ... ................... ................. ....... ...... .... .. .. 5
Bubble Leak Testing ......... .. ............ ........... ........ ...... ...... .. ........... .................. .. .. ....... .. ...... .. . 5
Related Documents .............................................................................................S

Logistics ..............................................................................................................6
Equipment/Materials ...........................................................................................6
Test Procedure ....................................................................................................7
Environmental Conditioning .................. ....... ............ ...... ... .................. ...... ........ ....... ... ...... ......... 7
Distribution Simulation ............................. .... .... ... ... ... ... ... .......... ........ ....... ... ... .. .. ..... ... .. .. .. .......... 7
Drop Test. .... .......... .................................................................. .. ............ ......... .. ................... 8
Vibration under Dynamic Load (Over-The-Road Trailer Simulation) ....... ........ ............... .... 9
Random Vibration (Pick-Up and Delivery Vehicle Simulation) ............... ........ .................. 10
Drop Test. .............. ........ .. .......................... .............................................. ....... ... .... .... .. ...... 11
Package Integrity Testing .............. ...... ........... ..... .... .. ........ ....... ...... ............ ....... ..... ....... .... ...... 12
Bubble Leak Test ........... ..... ...... ...... .. ..... .............. ...... .... .... .... ... ........ ......... ... ........ ............ 12
Disclaimer of Warranties .................................................................................. 13

Statement of Conformity .................................................................................. 14
Appendix A: Environmental Conditioning Data ............................................. 15
Appendix 8: Distribution Simulation Data ...................................................... 16
Appendix C: Bubble Leak Data ........................................................................ 17
I Report No. I
DOL Inc
DOL West
R1304158-01-00
Customer:
Bausch & Lomb
10200 Valley View Road Suite 101

Eden Prame MN 55344 Tel 952-941-9226
17371 Mount Wynne C1rcle Suite A Founta1n Valley CA 92708 Tel 714-979-1712
CONFIDENTIAL
Page 1 of 17
Fax 952941-9318
Fax 714 979-1721
21
REVISION RECORD
Table 1:
Revision Record
INTRODUCTION
Objective
The objective of this project was to perform testing on the Reusable Injector Handpiece
Ship Test & Reusable Injector Cartridge package design(s) for Bausch & Lomb as stated
in DOL, Inc. quote number 01304158-04 and Bausch & Lomb protocol numbers BLP9489
Rev A and BLP9490 Rev. A
Scope
This report documents environmental conditioning , distribution simulation , and bubble leak
testing on DOL, Inc. specimen number(s) 235488-235503 . Testing was done under
controlled laboratory conditions with equipment qualified to perform these tests.
SUMMARY OF TESTED SPECIMENS

Specimen Number(s)
Bausch & Lomb Protocol #
Quantity Tested
235488 - 235497
BLP9489 Rev. A
10 Shippers
235498 - 235503
BLP9490 Rev. A
6 Shippers
Table 2:
Break Down of Specimens per Bausch & Lomb Protocol
Specimen Number(s)
Testing Performed
Quantity Tested
235493 - 235497 &

235501 - 235503
Hot Conditioning
8 Shippers
235488 - 235492 235498 - 235500
Cold Condtioning
8 Shippers
235488 - 235503
Distribution Simulation - Post Conditioning
16 Shippers
235498 - 235499 &

235501 -235502
Bubble Leak- Post Conditioning I Distribution

Simulation
40 Trays
Table 3:
I Report No. I
DOL Inc
DOL West
Summary of Tested Specimens
R130415B-01-00
I Customer: I
10200 Valley View Road SUite 101

17371 Mount Wynne Circle Su1te A
Bausch & Lomb

Eden Pra1ne MN 55344
Fountam Valley CA 92708
CONFIDENTIAL
Tel 952-941-9226
Tel 714-979-1712
Page 2 of 17
Fax 952 941-9318
Fax 714979-1721
22
PACKAGING SYSTEM
Protective Package
Shipping Unit
The shipping unit(s) consisted of corrugated container(s) which contained 10 sterile barrier
system(s) . The approximate weight(s) and outside dimensions were as follows:
Specimen Number(s)
Weight (lbs.)
Length (in.)
Width (in.)
Height (in.)
235488 - 235497
0.20
7.00
3.00
1.50
235498 - 235503
0.15
4.00
3.50
2.25
Table 4:
Figure 1:
Shipping Unit Description
One of the Shipping Units as Tested
Sterile Barrier System

The sterile barrier system consisted of a single barrier tray with Tyvek Lid .
Figure 2:
I Report No. I
DOL Inc
DDLWest
The Sterile Barrier System
R1304158-01-00
I Customer: I
10200 Valley View Road Su1te 101

17371 MountWynneC1rcle Su1teA
Bausch & Lomb

Eden Prame MN 55344
FountamValley CA92708
CONFIDENTIAL
Tel: 952-941-9226
Tel 714-979-1712
Page 3 of 17
Fax 952 941-9318
Fax 714-9791721
23
PRODUCT
Reusable Injector Handpiece & Reusable Injector Cartridge
RESULTS SUMMARY
Acceptance Criteria
The acceptance criteria have been outlined in Bausch & Lomb protocol numbers BLP9489
Rev A and BLP9490 Rev. A.
Bausch & Lomb personnel are responsible for determining the acceptance criteria for the
package and product.
Environmental Conditioning
Environmental conditioning was performed on 16 shipper(s) per Bausch & Lomb protocol
numbers BLP9489 Rev A and BLP9490 Rev. A Sec. 10.1. The following table describes
the conditions and durations for environmental conditioning:
Test Interval
Specimen Number(s)
Condition
Duration (hrs.)
235488 - 235492 &

235498 - 235500
-10C (+/-SC)@ Uncontrolled RH
72
sooc (+/-SC)@
8S% RH (+/- S% RH)
48
60C (+/-SC) @
8S% RH (+/- S% RH)
24
Initial Test
235493 - 235497 &
235501 - 235503
TableS:
Environmental Conditioning Cycle
The data for the environmental conditioning is located in Appendix A of this test report.
Distribution Simulation Testing

Distribution simulation testing was performed on 16 shipper(s) per Bausch & Lomb protocol
numbers BLP9489 Rev A and BLP9490 Rev. A Sec. 10.3 - 10.6. The distribution
simulation cycle is outlined in the table below:
Test Interval
Specimen Number(s)
Condition
Post Environmental Conditioning
235488 - 235503
ISTA 3A - Shock and Vibration
Table 6:
Report No.
Distribution Simulation Cycle Summary
DOL Inc
DOL West
R1304158-01-00
I Customer: I
10200 Valley V1ew Road Su1te 101

17371 Mount Wynne C1rcle Su1te A
Bausch & Lomb

Eden Pra1rie MN 55344
CONFIDENTIAL
Tel 952-941 9226

Tel 714 979 1712
Page 4 of 17
Fax 952-941-9318
Fax 714-979-1721
24
Upon completion of the distribution simulation testing some minor damage was observed
on the shipper(s), such as scuffing and creasing. This type of damage is common within
the distribution environment and is not considered to be a critical defect.
The data for the distribution simulation testing is located in Appendix 8 of this test report.
Package Integrity Testing

Bubble Leak Testing
Forty trays were bubble leak tested per ASTM F 2096-11 and Bausch & Lomb protocol
number BLP9490 Rev. A. All packages passed the bubble leak test. The results are
shown below:
Test Interval
Specimen Number
Number of
Samples Tested
Pass
Fail
Post Conditioning I
Distribution Simulation
235498 - 235499
20 Trays
20
235501 - 235502
20 Trays
20
Table 7:
Bubble Leak Test Results
The data for the bubble leak testing is located in Appendix C of this test report.
RELATED DOCUMENTS
Standards
ISTA 3A (2008): General Simulation Performance Test Procedure for Packaged-Products for Parcel
Delivery System Shipment 70 kg (150 /b) or Less
ASTM F 2096-11 : Standard Test Method for Detecting Gross Leaks in Packaging by Internal
Pressurization (Bubble Test)
References
DDL, Inc. Quote# 01304158-04
Bausch & Lomb Protocol# BLP9489 Rev. A: Reusable Injector Handpiece Ship Test Protocol
Bausch & Lomb Protocol# BLP9490 Rev. A: Reusable Injector Cartridge Ship Test Protocol
DDL, Inc. S.O.P. # 2006-12 : Environmental Chamber Test Activities
DDL, Inc. S.O.P. # 6011-08: Distribution Simulation Tests
DDL, Inc. S.O.P. # 6047-08: Work Instruction for Bubble Leak Testing
Table 8: Standards and References
I Report No. I
DOL Inc
DOL West
R1304158-01-00
Customer:
Bausch & Lomb
10200 Valley V1ew Road SUite 101

Eden Prame MN 55344
CONFIDENTIAL
Tel 952-941-9226
Tel 714-979-1712
Page 5 of 17
Fax 952-941-9318
Fax 714-979 1721
25
LOGISTICS
Specimen(s) 235488- 235503 were received on 13 May 2013.
Environmental Conditioning:
Started: 24 May 2013
Completed: 27 May 2013
Distribution Simulation Testing:
Started: 04 June 2013
Completed: 05 June 2013
Bubble Leak Testing:
Started: 06 June 2013
Completed: 06 June 2013
Specimen(s) 235488 - 235503 were returned to Bausch & Lomb on 07 June 2013.
EQUIPMENT/MATERIALS
The following equipment was used to complete these tests:
Equipment Name (Gage ID)
Asset No.
Calibration Due
Climate Chamber 069
004007
12-Mar-14
Thermocouple Probe
002748
19-Feb-14
Climate Chamber 067
004004
07-Feb-14
Thermocouple Probe
001207
19-Feb-14
L.A. B. Accudrop Swing Arm Tester
001030
Verified with ruler
Medium Vibration System
002862
08-May-14
Ruler
002701
28-Nov-14
Package Tester
001001
11-Feb-14
Pressure Gauge
002810
05-Nov-13
Equipment Name (Gage ID)
Serial No.
Calibration Due
Temptale4 Sensor (584)
3730290471
24-Jan-14
Temptale4 Sensor (631)
3708391316
25-Apr-14
Table 9:
I Report No. I
DOL, Inc.
DOL West
Equipment/Materials List
R1304158-01 -00
Customer:
10200 Valley V1ew Road Suite 101

Bausch & Lomb

Eden Prame MN 55344
CONFIDENTIAL
Page 6 of 17
Tel 952-941-9226
Tel 714-979 1712
Fax 952 941-9318
Fax 714-979-1721
26
TEST PROCEDURE
Environmental conditioning was performed per Bausch & Lomb protocol numbers BLP9489
Rev. A & BLP9490 Rev. A Sec. 10.1, and DOL, Inc. S.O.P. number 2006-12. The test
conditions were as follows:
-10C (+/-soC) at uncontrolled RH for 72 hours minimum (specimen #'s 23S48823S492 & 23S498 - 23SSOO )
S0C (+/- soC) at 8S% RH (+/- S% RH) for 48 hours minimum (specimen #'s 23S493
- 23S497 & 23SS01 - 23SS03)
60C (+/-soC) at 8S% RH (+/- S% RH) for 24 hours minimum (specimen #'s 23S493
- 23S497 & 23SS01 - 23SS03)
A summary of the environmental conditioning is presented in the results portion of this test
report and the data is located in Appendix A
Distribution Simulation
Distribution simulation testing was performed per Bausch & Lomb protocol numbers
BLP9489 Rev. A & BLP9490 Rev. A Sec. 10.3- 10.6, and DOL, Inc. S.O.P. number 601108. The packaged product, as described previously, was subjected to the following
schedules. Each schedule is described in the order that it was performed during the test.
A summary of the distribution simulation testing is presented in the results portion of this
test report and the data is located in Appendix B.
I Report No. I
DOL Inc.
DOL West
R1304158-01-00
I Customer: I
Bausch & Lomb
Page 7 of 17
10200 Valley View Road Su1te 101

Eden Pra1ne MN 55344 Tel 952 941 9226 Fax 952-941-9318
17371 Mount Wynne C1rcle Su1te A Fountain Valley CA 92708 Tel 714-979-1712 Fax 714-979-1721
CONFIDENTIAL
27
Drop Test
The test levels and method for this schedule of the distribution cycle were intended to
determine the ability of the shipping units to withstand the hazards occurring during manual
handling such as loading , unloading, stacking , sorting, or palletizing. The main hazards
from these operations were the impacts caused by dropping or throwing. Size, weight, and
shape of the shipping units will affect the intensity of these hazards.
The drop heights, the number of drops and the shipping units' orientations at impact
performed on these packages are presented below in Table 9.
Drop Height
Orientation
18inches
3-4 Edge
3-6 Edge
4-6 Edge
3-4-6 Corner
2-3-5 Corner
2-3 Edge
1-2 Edge
36inches
Face 3 Bottom
18inches
Face 3 Bottom
Table 10:
Test Method ISTA 3A First Drop Sequence.
This procedure was performed using a drop tester.
Figure 3:
I Report No. I
DOL Inc
DOL West
This photograph shows the setup for the drop test. (18" bottom)
R1304158-01 -00
I Customer: I

Bausch & Lomb

Eden Prame MN 55344
CONFIDENTIAL
Tel: 952-941-9226
Tel. 714-979-1712
Page 8 of 17
Fax: 952-941-9318
Fax 714-979 -1721
28
Vibration under Dynamic Load (Over-The-Road Trailer Simulation)

Overall acceleration levels were 0.53 grms with total test duration of two hours. The
package was constrained but not secured to the table for this element of the test. Table 10
below denotes the PSD level for Over-The-Road Trailer Simulation.
Frequency (Hz)
1
3
5
7
12
15
Over-all Qrms: 0.53
Duration : 120 minutes
Table 11:
PSD (g /Hz)
0.0007
0.02
0.02
0.001
0.001
0.004
PSD (g /Hz)
0.004
0.001
0.001
0.003
0.003
0.000004
Frequency (Hz)
24
28
36
42
75
200
ISTA 3A Frequency Power Spectral Density Level Over-The Road Trailer Simulation.
This procedure was performed using a vertical linear vibration test system .
Figure 4:
I Report No. I
DOL Inc
DOL West
This photograph shows the setup for the vibration under dynamic load test.
R1304158-01-00
Customer:
Bausch & Lomb
10200 Valley V1ew Road Suite 101

Eden Prame MN 55344 Tel 952-941-9226
17371 Mount Wynne C1rcle Su1te A Fountain Valley CA 92708 Tel. 714-979-1712
CONFIDENTIAL
Page 9 of 17
Fax 952-941-9318
Fax 714-979-1721
29
Random Vibration (Pick-Up and Delivery Vehicle Simulation)

Overall acceleration levels were 0.46 gnns with total test duration of thirty minutes. The
package was constrained but not secured to the table for this element of the test. Table 11
below denotes the PDS level for Pick-Up and Delivery Vehicle Simulation.
Frequency (Hz)
PSD (g 2/Hz)
Frequency (Hz)
PSD (g 2 /Hz)
0.001
24
0.001
0.035
29
0.0001
0.035
50
0.0001
0.0003
70
0.002
13
0.0003
100
0.002
15
0.001
200
0.00005
Over-all 9rms: 0.46

Duration : 30 minutes
Table 12:
ISTA 3A Frequency Power Spectral Density Level Pick-Up and Delivery Vehicle
Simulation.
This procedure was performed using a vertical linear vibration test system .
Figure 5:
I Report No. I
DOL Inc
DOL West
This photograph shows the setup for the vibration test.
R1304158-01-00
Customer:
10200 Valley Vtew Road SUite 101

17371 Mount Wynne Ctrcle Suite A
Bausch & Lomb

Eden Pratne MN 55344
Fountatn Valley CA 92708
CONFIDENTIAL
Tel 952-941-9226
Tel 714 979-1712
Page 10 of 17
Fax 952 941-9318
Fax 714-979-1721
30
Drop Test
This test schedule has been described previously and was repeated on the test specimens.
The drop heights, the number of drops and the shipping units' orientations at impact
performed on the packages is presented below in Table 12.
Drop Height
Orientation
18inches
3-4 Edge
3-6 Edge
1-5 Edge
3-4-6 Corner
1-2-6 Corner
1-4-5 Corner
36 inches
Face 3 Bottom
18inches
Face 3 Bottom on Hazard
Table 13:
Test Method ISTA 3A Second Drop Sequence.
This procedure was performed using a drop tester.
Figure 6:
I Report No. I
DOL Inc
DOL West
This photograph shows the setup for the drop test (18" bottom on hazard).
R1304158-01-00
Customer:
10200 Valley Vrew Road Surte 101

17371 Mount Wynne Crrcle Surte A
Bausch & Lomb

Eden Prarrre MN 55344
Fountarn Valley CA 92708
CONFIDENTIAL
Tel 952-941-9226
Tel 714-979-1712
Page 11 of 17
Fax 952-941-9318
Fax 714 979-1721
31
Package Integrity Testing

Bubble Leak Test
Bubble leak testing was performed per ASTM F 2096-11 and DOL, Inc. S.O.P. number
6047-08.
The test method is designed to detect open pathways, channels, or voids across the seal
area intended as a primary sterile barrier, and to detect pinholes in non-porous materials.
Samples were prepared for testing by cutting a small hole in the tray for connection from
the air source to the package. The test apparatus listed in the "Equipment/ Materials"
section was used as the air pressure source. A test sample was used to determine the set
pressure by using a 0.008 inch wire to create a known defect in the package. The porous
package was submerged approximately one inch in a water bath for at least five seconds
with no air pressure being applied to the package. The pressure was then increased slowly
until a steady flow of bubbles came from the known defect created in the package. This
pressure was then used to test the remaining packages. The packages were observed for
evidence of leakage in the form of a steady stream of bubbles emanating from the
package.
Figure 7:
The Bubble Leak Test Set-up
A summary of the bubble leak testing is presented in the results portion of this test report
and the data is located in Appendix C.
I Report No. I
DOL Inc.
DOL West
R1304158-01-00
I Customer: I

17371 Mount Wynne Circle Su1te A
Page 12 of 17
Bausch & Lomb

Eden Prame MN 55344
Fountain Valley CA 92708
CONFIDENTIAL
Tel 952-941-9226
Tel 714 979-1712
Fax 952-941-9318
Fax 714-979-1721
32
DISCLAIMER OF WARRANTIES
ALL WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY THAT
THE PRODUCT OR PACKAGING TESTED IS MERCHANTABLE, FIT FOR A
PARTICULAR PURPOSE, OR IN COMPLIANCE WITH ANY FEDERAL, STATE OR
LOCAL REGULATIONS, ARE DISCLAIMED. In no event shall DOL, Inc. liability exceed
the total amount paid by Bausch & Lomb for services rendered.
A Quality Assurance program should be in place to ensure that the manufacturing process produces
products/packages of equivalent performance to those tested here. This is solely the responsibility of the
manufacturer. DDL, Inc. takes no responsibility for the quality of products/packages produced hereafter,
other than to certify the design of those physical test systems actually tested by DDL, Inc. DDL, Inc. takes no
responsibility for the use, acceptance or non-acceptance of this data by government regulatory agencies.
In the event of future changes to the referenced test procedure(s), it is the responsibility of Bausch & Lomb
to determine whether additional testing is necessary to verify that the product and/or packaging certified here
remains in compliance with requirements.
I Report No. I
DOL, Inc.
DOL West
R1304158-01-00
I Customer: I
Bausch & Lomb
Page 13 of 17

Eden Pra1ne MN 55344 Tel 952-941-9226 Fax 952-941-9318
17371 Mount Wynne C1rcle SUite A Fountain Valley CA 92708 Tel 714-979 -1712 Fax 7 4-979-1721
CONFIDENTIAL
33
STATEMENT OF CONFORMITY
DOL, Inc. has completed the above stated testing services performed in accordance to
applicable standard good laboratory practices and/or standards identified within this report.
Testing has been completed as described herein.
The following list of exceptions occurred during testing performed at DOL, Inc.:
None
All materials, equipment, methods, and processes used to perform the described testing
have been standardized, calibrated, and monitored in accordance with prescribed
guidelines, standard operating procedures, and the supervision requirements of DOL, Inc.
All raw data obtained from this testing by DOL, Inc. personnel is archived at DOL, Inc.
The signatures below are in compliance with 21 CFR Part 11 .

Testing performed by:
Ed J . Kehoe, Ashley D. Hall, Adam D. Stuessel, and Pone

klimvan
Digitally signed by Ahmed lssa
DN: cn=Ahmed lssa, o=DDL, Inc,
ou=Operations,
email=ahmed.issa@testedandproven.
com,c=US
Reason: I am the author of this
document
Date: 2013.06.11 12:18:21 -05'00'
f\ m e
Project Manager:
Iss a
Ahmed A. lssa
Project Manager
Technical Approval:
Digitally signed by Luke J. Munroe

DN: cn=Luke J. Munroe,
email=luke.munroe@testedandproven
.com, o=DDL, Inc., ou=Operations,
c=US
Reason: I am approving this document
Date: 2013.06.11 12:26:02 -05'00'
Luke J.
Munroe
Luke J. Munroe
Packaging Project ManagarDigitally signed by Tammy J. Nelson

DN:cn=TammyJ.Nelson,
email=tammy.nelson@testedandpro
ven.com, o=DDL, Inc.,
ou=Administration, c=US
:~~~:~~~m approving this
Date: 2013.06.11 13:03:44 -05'00'
Tam my
Quality Approval:
J. Ne I50 n
Tammy J. Nelson
Quality Specialist
I Report No. I
DDL Inc
DOL West
R1304158-01 -00
Customer: I
10200 Valley Vtew Road Sutte 101

17371 Mount Wynne Ctrcle Suite A
Bausch & Lomb

Eden Prame MN 55344
Fountatn Valley CA 92708
CONFIDENTIAL
Tel: 952-941-9226
Tel: 714-979-1712
Page 14 of 17
Fax. 952-941-9318
Fax 714-979-1721
34
APPENDIX A: ENVIRONMENTAL CONDITIONING DATA
I Report No. I
DOL Inc
DDLWest
R1304158-01-00
Customer:
10200 Valley V1ew Road Swte 101

17371MountWynneCircle Su1teA
Bausch & Lomb

Eden Prame MN 55344
Founta nValley CA92708
CONFIDENTIAL
Tel 952 941 -9226

Tel714-979-1712
Page 15 of 17
Fax 952-941-9318
Fax 714-979 -1721
35
Equipment Information
Tesled and Proven.
Customer: Bausch & Lomb

Job number: -'"1.;;;..30;;..4....;.1.;;.;58:;....__ _ _ _ _ __
Customer PO: .;..N::..A:...__ _ _ _ _ _ _ __
Product Tested: .;.;M.;.;:e;,::cd;,::cica=..:.I-=D;,::ce.:..:vic::.:e:;....__ _ _ __
Lot Number:.;..N;.;..A;....__ _ _ _ _ _ _ __
Equipment Used
GageiD
Asset Number
c :r
(f)e>
~'s=:U.-
Lf<)o 1./
Chamber(s):
~
l4'-"1~
Tc- l'vtt At 11o (Z.;l

Probe(s):
AI
"4 /
r~
J _
~1-oJ)t::t J) J ~
End Date
2H- irmv- 1-3
Z-l-1?,#7 I I
1::.-f.(
li.lmtrl-1~
! ~ 11,4 f: I J
de.
7IZ-
A~
rl
/.:::J'L
Calibration Due Date
Serial Number
Verified by
Initials
Start Date
r~
I '1 ~l.rl '1
L<[
Zf~/~1
Start Date
End Date
Verified by
Initials
l-t"'tifi- I) 1 '/. 1"})4 YdS
&"'~:..
Sensor Monitor(s):
,
A/4/ [d'r
Specimen #'s :
..,,. A-. I'"~
/F't:.
235488-235492, 235498-235500
Worksheet Approval: -----'llttU-l!..__.3:...3...z.._-.c..~:.=::p.-::..~1"-'3
lnilials I Dale
Equipment Approval
by: _ ___./f1J5=~~---=';...-..JJ~l.t~o1..:.-.....:1;...3=--
lniloals I Dale
Form # 8256-03
5/23/2013
CONFIDENTIAL
36
Taated and Proven.

Job number: -,:1,;30:::.;4.:.:1..::5:::.8_ _ _ _ _ _ _ __
Customer PO: NA
Product Tested: ~M;=e~d,...ic""'at'"'o=-e-VI::-.c-e_ _ _ _ _ __
Lot Number:-"N::;A,___ _ _ _ _ _ _ _ __
/l_
SOP 112006 Rei.

Test Standard: Per B&L Protocols. Sec. 10.1
Test Cycle/Conditions:
-1 DC +/-5C @ Uncontrolled RH for 72hrs mini
c:t</ 't.J~-ty rl
Profiled by:
~wdBy
(If AppH<abio )
Program Verification:
pr Applal blo l
Doq8011rd Vorilicotlon:~
Digital Output1:
Ovortomp Sot Point:
Owrtomp Verification:
Dolo
:.zv Z.l{-f11At-JJ
Approved By
Ollie
Milestones
Initial Start Daterr.me : t...:::T-r=~-ftl'+--:s+':"'J<-<LL"'-!-....<ti[:A-:--f---T:H---I~S>;i-----__.;:"4;_;"-4---l
Cycle Start Daterrlme:
~~ 0C @U~oo~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~iiii~~i~
4
RH for 72hrs mini
C cia End Oatell'lme ;

Specimen fl's:
235488-235492, 235498-23~~0
e1< r a :mrtt
A~ By
Specimen(s) Removed:
Dolo
p~l.I''Adlf: I)
Romowd By
Worksheet Approval:
Da1e Approval.
Oakl
Form # 8232-07
/11 '- j'
C( f'\-
1_3
5/23/2013
CONFIDENTIAL
37
Equipment Information
Tested and Proven.

Job number: ..:.1.=.;30::...;4~1::..:58:....__ _ _ _ _ __
Customer PO: ..;..N::...;A'----------Product Tested: ..;.;M.;.;:e..::.di;.:;.;ca:;.;.I..;;:D..::.ev.:..:.ic::..:e'------Lot Number: ..:..N::..;A;___ _ _ _ _ _ _ __
E<Julprnent Used
GageiD
Asset Number
6<f
C!>O l.foo 7-
ll- t11AR, 1'1
L ({
Chamber(s):
A4
ltr
/~
Start Date
~ l.
Probe(s):
~
=1'1 i?
r 'tr~
7./ 'llf~ ~~ rJ Fk...
21./ mAr- L3
z.J.Y'!_,/'r ll
.,./;;c.
1=7-J ~"l:. So ~~ ~
I
.I
~I
Specimen #'s :
(if(
r_~
--;,crt"
Serial Number
Sensor Monltor(s):
l ~ &='e b -t Lf
AIJI'J
/Y
Verified by
Initials
l'i-111A'iJ3
1-
'rc /'v.. 6f'
End Date
'1 :r,.,<J.-v Itt
,R .. .-A ~ fj
Start Date
W-11/A 'i/.1
End Date
Verified by
Initials
v \lhll'l'- J) cfL
.c. 17
235493-235497' 235501-235503
Worksheet Approval: _ _ _
_./jth;:'..p.Jut::::.---'2~3"'"~~
9r:-::.J/'-""'$
Initials I Date
Equipment Approval by:
-....,..,.._!hk"-=.~---"hl......-....;1...,u..,!1<..L::..-..r.../~;J~
Inilials I Date
Form # 8256-03
5/23/2013
CONFIDENTIAL
38
E ~ voronmental
Tealtd and Proven.
Condition ng
=--~'~z.==--

Job number: ~1.,::3::.04.;..1;.;5;.::8_ _ _ _ _ _ _ __
Customer PO: NA
Product Tested: ~M:,:;e:.,d,..IC-8';""1o=ev-,c-e_ _ _ _ _ __
SOP #2006 Ret.

Test Standard : Per B&L Protocols. Sec. 10.1
Lot Number: .:.N:::.A;__ _ _ _ _ _ _ _ __

Test Cycle/Conditions:
50C +/-5C @ 85% RH +/-5% for 48hrs mini

60C +/-5C @ 85% RH +/-5% for 24hrs mini
i.'k /z ~ '1'J?A4f ~t
Profiled by:
(II Appl~bleJ
App;o\/Od By
Program Verification:
(If 1\ppleobla}
~~ 2J lt7Jt'j-/ j
Ap piD'-'Od 13y
Milestonas
DaqBoard Verification : ~
Digital Outpull :
Overtemp Set Point:
Overtemp Vefllicat1on.
Dalt
Dole
Date
Initial Start DatefTime : 17'F.-LLI.UJ~.,L-I-+:..:;~::..LU.:.+--,Pf:.P.:-+--::~..qr-+->o~~----l'"'-1:.4.-"":....L----I
f
~~~"~"~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ii~~~~~~iJ
SEE PROFILE:
C cle End DatefTime :

Specimen #'s
235493-235497, 2355Dr'}.5~D3
t:."'lL ~:.17-'/Y./)
Approwd By
Worksheet Approval
Date
Data Approval
Speclmen(s) Removed .
Form # 8232-07
512312013
CONFIDENTIAL
39
APPENDIX B: DISTRIBUTION SIMULATION DATA
I Report No. I
DOL Inc
DOL West
R1304158-01-00
Customer:
Bausch & Lomb
10200 Valley V1ew Road SUite 101

Eden Pra1ne MN 55344
CONFIDENTIAL
Tel 952-941-9226
Tel 714-979-1712
Page 16 of 17
Fax 952 941-9318
Fax 714-979-1721
40
ISTAJAWorbheel
Postv EC
Cold
DOL Job Nil: 1304158

CUSTOMER: Bausch & Lomb
Work.uhoot Approval
=r
:J!~-I.fl
..
PO Nil: NA
PRODUCT NAME: Reusable ln]eclor Handp1ece ShiP Tesl
B&l Praloool: BLPG43i Rev
TEST TYPE: ISTA 3A 2008

PACKAGE TYPE: Standud
SOP No.: 6011 R81. No.
Length:
Wkltll:
Height:
DIM:
TDT
SEQ.
- NO.
CATEGORY
7
:J
1
Initial Drop lfelgtlt (ln.):

Stick Height (ln.):
Fntor:
ln.
ln.
112 ln.
c 20
Shlpplftlll wt. (lb1.):
--
T1IBT
lEST
TYJII!
IITH8ITY'
JH);I
18''. Edae I~
18" Edae 3-6
18'' Ed1111 .C-61
18'' Comer ~-61
18" Comer 2-3-5
18"-Edae 2-3
18" Edllll 12
38" F- 3)
18" Face (3}
SHOCK
18
108
00035
DROP
INDIVIDUAL
PACKAGE
'DnHI Tatllf
t/
"',
.......
,.........
_,_
231410
..,
"'v
-~
llffl'r_
../.
VIBRATION
OVER THE ROAD

SPECTRUM
WITHOUT TOP LOAD
TL with face 3 down = 11 08-HI X L X W X 0.0035

TL = 1081 51x7 x3x0 0035
8
calcullllad TL Is rounded UD to nexl51b. ~
1 Hour with,_ :s down liD
a.u-
....
r'KIA/
v
..
\/
lQ.M..'V
T wllh face 6 down = 1108-t.l X W X H X 0 0035

Tl = 11l8-71x3x1 .5x00035
2
Cek:ullled TL IS rounded UD Ia next 5 lb lnc:nlment
~ Mlnul w11t1 , _ down
e o.u -
VIBRATION
~Tete
..
PICK-UP & DELIVERY

SPECTRUM WITHOUT
TOP LOAD
Minulas wllh , _ 3 down mD.4&-
1 - ~~
I "f'
'\
SHOCK
110'1'
18''- Edoe ~
18" Edllll 3-8
18" Ed01 ,15
18'' CQITier (3_.-6
1!1" Comer 12-6
18" Comer 11_.-5
DROP
INDIVIDUAL
PACKAGE
[oro, TAler
../
./
,/
./
,/
.,/
./
.,/
.,.
[(Zl;Vl
.,/
./
;/_
./
##17
(1f1:/l/l
::TIA/i
U!'rH
'J
Tl with lace oil down = 1()8.W} X l x H x 0.0035

Tl =_tl08-3jx 7 X 1.5 X 1:1.1)035
CalcUlated TL Is roundedJII)_IO next 5 lb. 111C1111T111n!
31 Minutes with F - 4 down IIIII. A_.,.__
Mbndlon Tble
v
v
,/
\/
--~
./
./
V'
"
Photo
./
./
...,
"
liP!'.
.,/
,/
""".
Z3MI2
231411
,/
v'
.,""'
.,
.,
"
ltfJ'IC
f".llAA
38" FIICe 3
1rF-1lllaDrll . . . .
...,
.J
,."'
./
-"'
v
" '!"
\/
i/
-.,
_.,
.._
rt7't
...
.,
"
.,"
V"'
/
/
""
..,_
J
V"'
./
AoYl"'i!
..,.
-~
.,.,.
./
\;1"
./
..;"
~
""
MD"
11'1"
PP"11lfl11 pkg. description photos 10 be laken after ISTA tesllng Is complete:
J;4Jl.lll Photo of s~rlcortt.tner (lncludng ann wldlfferent dimensions}
Fonn 1182311-{12
R....-By
l/llk=
CONFIDENTIAL
Dolo '
/,~"lo(l\~/3
Page 1 of1
41
ISTA 3A War!l1/leel
Pastv EC
HI>!
i;
DOL Job .. : 1304156

Worktshool Approval
a.
PO .. : NA
PRODUCT NAME: ReusaDie ln1eclor Handp1ece Sh p Tesl
B&l PrDtoDOI:
TEST TYPE:
PACKAGE TYPE:
SOP No.:
DIM:
Lengtll:
Wlcfttl:
Hllght:
NO.
11i.8T
CATJ!GOIIIY
SHOCK
SEQ.
BLP948ll Rev A
ISTA 3A 2008
Standard
6011 Rei. No.:
Initial Drop HIIQht (ln.):

St8ok Height (ln.):
Factor:
ln.
ln.
1 112 ln.
SlllpplntJ
wt. (llle.):
OVER-THE -ROAD
SPECTRUM
WITHOUT TOP LOAD
DICM
Dl.a
IN1DIITY
/k?'
19"- EdQtl, ~
19"-Edoe,J.e
18"- Eda. , 4-61
18"- Comer 1~-6
18"- Comer 2-3-S
18"- Eclae !2-3
9" Edoe 11-2.l
38"-F- 3
19"- Face 3
IDroiiTVIBRATION
020
TDT
TEST
TYPII
DROP
INDIVIDUAL
PACKAGE
16
106
OOCllS
\/
v.,
/
,/
,
,
a/
./
./
"
V'
111117
~'7
TL with faCIO 3 down = 1011-H\ x X W X 0.0035

TL -'_(1()6.1.5 )X 7 X 3 X 0.0035
9
Calcullltad TL Is rounded uo to next 51b. lncrermmt
1 Hour with F - S down C O.IS . , _
.)'I"IAA
:IMGI
Dial
./
.,/
../
./
./
_/
""
../
..,..
.......
../
Pllola
t7~\l
,""
"
,.
./
o/
""
-.
-
2 HQ1
../"
;/
./
tr
........lluniiMfs
./
../
/
/
./
..,
v
1110
"F
00/IA
,......;r All
(r;;Ifl_
~-
TL with face 4 down - 109-Wl x L x H x 0 0035

TL- 108-3 )X 7 X 1.5 X 0.0035
"'
Calcula!ad Tl IS rounded UP lo next 5 lb incremanl

31 Minutes with F - 4 down \1111.13 InN
li->AA.~
-../
../
r-.-I'HJ
TL with loce 6 down = 108-l X W X H X 0.0035

TL = 109-7 x 3x1 .5x00035
2
Celcutatad TL IS rounded UP to next 5 lb. increment
31 Minutes with 1'- 1 down
1.13 -
Vlllrdon Tallie
...,..
'C/AJ...'-J
..,./
..;
~
'i"
VIBRATION
IVlllntlon Tallie
PICK -UP & DELIVERY

SPECTRUM WITHOUT
TOP LOAD
SO Mint.Ces with F - 3 down
18"- Corner (1-4-5)

36"- F - (3)
IDroiiT-
,,"""
..,"""
18"- Comtr 1-2-6
..,
J
llfllt
1rl'- 131 on Huard Bloak
"\./
./
18"- Edoe 3-6

18" Edal 1-5
18"- omer 3-4-el
DROP
INDIVIDUAL
PACKAGE
J'b'JT
-"',
1 9"- Edo&l~
SHOCK
"'
11!11.41 ,,_
\/
"'
.:.n/1.1'1
"
,,"'
,.
,/
\/"
./
~I pkg. description photos to be taken after ISTA testing Is complete
(tlJllll
Photo of shtpper/Contan.r (lndudlng ones wlclfl'erent dtrnenlions)
Form 1182J0.02
R - !lr"
fJtJr
Cote-Uf1~/ _)
CONFIDENTIAL
\/
,
../
./
.,.,."'
""
i/
v:
t!HJ.,
.,""
.,"
..,.....
...,
.......
..,.
1":n
~
-
Jl h
+.'.t')
~
Page 1 of 1
42
ISTA 3A WOI1tshoot
Cold
Poslv EC
DOL Job Nil : 1304156

PO Nil: NA
PRODUCT NAME: Reusable Injector Cartndge Ship Test
8&1 Protocol: BLP9489, Rev A
TEST TYPE: ISTA 3A - 2008
PACKAGE TYPE : Standard
SOP No.: 6011 Rei. No.:
Length:
4
ln.
DIM:
Width:
3 112 ln.
Height
2 114 ln.
Factor:
Shipping wt. (lbs .):
TEST
TEST
TEST
TYPE
INTENSITY
DROP
INDIVIDUAL
PACKAGE
DroDTester
VIBRATION
OVER-THE-ROAD
SPECTRUM
WITHOUT TOP LOAD
Soed!Hn Numbers
235411
fff'_'/
18"- Edae (3__.}

18'- Ecloe (3-6}
18' Edae (4-6)
18"- Comer 13+61
1B" Comer 12-3-51
18"- Edge (2-3}
111'- Edae (1-2}
38"- Face (31
18"- Face C3l
SHOCK
0 15
CATEGORY
SEQ.
. NO.
18
106
0 0035
Initial Drop Height (ln.):

Stack Height (ln.):
23A88
v'
./
,/
,/
....
v'
./
./
../
./
./
~,
..,
6HAII
V"
B/)_#1
VIBRATION
VIbration Table
"
...
'rJAI\""
./
v
,/'
f~A/l
lfll'?
IJtiAA
""""'
r-KTAA
rern
'./
TL with face 4 down= (108-Wl x LX H X 0.0035

TL = (108-3.5Jx 4 X 2.25 X 0 0035
TL with face 6 down= (108-L} X W x H X 0.0035

TL = {108-4jx 3.5 x 2.25 X 0 0035
3
Calculated TL Is rounded up to next 5 lb. Increment
30 Minutes with FKe I down ft 0.53
nn
~..0.'~
\./
i./
{~/.J.-
\./
"
PIC K-UP & DELIVERY

SPECTRUM WITHOUT
TOP LOAD
30 Minutes with Face 3 down Q 0.41gmta
II'P7
or
DROP
INDIVIDUAL
PACKAGE
18'- Ecloe (3-4)

18' Ed!ie (3-8)
18" Edae C1-5l
18"- Comer C3+6l
18"- Comer (1-2-61
18" Comer 11-4-51
38' Faee_i3l_
1r- Fece l l l ttaul'lll Bleck
(KY./
SHOCK
1~Tea11tr
......
./
"
_-
All
Calculated TL is rounded UD to next 5 lb. increment

30 Minutes with Face 4 down C 8.53 anwa
Vnntion Table
PltoCo
"
./
TL with face 3 down = (1 08-tj}_X LX W X 0.0035

TL a (108-2 25 )X 4 X 3.5 X 0.0035
8
Calculated TL Is rounded uo to next 5 lb. Increment
1 Hour with Face 3 down 1.53 anna
.,
2314!11
( ..rl/1/\
"
o/
o/
ffi,HJ
RB.,
..,
~:)
-to:"~
""
../
..,
V"
./
./
./
./
v_,.
!V
.......
I
H"'J
i'Y::L
lfiTI"
P~u_ct) pkg. description photos to be taken after 1STA testing Is complete

~I Photo of shipperkontarnor (Including ones wldiflarant dlmensoons)
Form 18230.02
Reviewed By
/l4z;
CONFIDENTIAL
Date
6=-Zl l(tt-1)
Page 1 of1
43
ISTA 3A Worksheet
Hot
Postv EC
DOL Job Nl: 1304158

PO Nl: NA
Tes'f Technician :
VIV"' IY,.... '
;;j
!t
PRODUCT NAME: Reusable lnJeclor Cartndge Shrp Test

B&l Protocol:
TEST TYPE:
PACKAGE TYPE :
SOP No.:
DIM:
Length:
Width:
Height:
TEST
TEST
CATEGORY
TYPE
SEQ.
, NO.
BLP9490 . Rev A
ISTA 3A- 2008
Standard
6011 RJ. No.:
4
ln.
3 1/2 ln.
2 1/4 ln.
Initial Drop Height (ln.):

Steck Height (ln.):
Fec:tor:
0 .15
Numbers
TEST
231111
18"- Edge (341

18"- Edge (3-8)
18"- Edge (4-6)
111"- Corner 13-4-6)
18"- Corner 12-3-51
18"- Edoe 12 31
18"- Edge (1 -2)
38" Face C3l
18"- Face 13>
lftl7
TL with face 3 down= 1108-HI XL x W x 0.0035

TL = 1108-2.25 IX 4 X 3.5 X 0.0035
8
Calculated TL Is rounded up to next 5 lb. increment
1 Hour with Face 3 down ft 8.53 anne
f }11/V(
DrooTester
VIBRATION
OVER-THE-ROAD
SPECTRUM
WITHOUT TOP LOAD
IVnw.t~on Table
,...,.
,./
..,
TL with face <4 down = 11 08-WI x L x H x 0.0035

TL = I 1083.5 IX <4 X 2.25 X 0.0035
4
Calculated TL is rounded up to next 5 lb. increment
30 Minutes with Fec:e 4 down Q 0.53 Gnftl
PICK-UP & DELIVERY

SPECTRUM W ITHOUT
TOP LOAD
30 Minutes with Fec:e 3 down C 0.4& anna
DROP
INDIVIDUAL
PACKAGE
18" Eckle 13-4l

111" Edae (3-6)
111"- Edae 11-5)
111"- Comer 13-4-Gl
18"- Comer 11-2-61
111"- Comer 11-4-51
38"- F-(3)
./
./
o/
.,/
IDroo Tester
,../
MJ7
;v
../
A/II?
./
._/
;:;;;"
(~
--;:::7
AU'?
lmM
-1-A-t.A.I
L.FIII
[;,rft
\7
\./
AA.
I~Jk\.."'\
llTVf7T
nY/7
v'
./
..,.
J
..,....
ll!H
11. FIICI (:IJ Oft . . _ _ IIKII
,./
-------
('/fl/1;
\7
o/
\/'
V'
./
,r.
v'
-~
'L7
./
/
SHOCK
_
EqUipment ..s-ue
Approvo
t..AI\' J
'<?A~.)
Pilote
./
./
231503
......
./
./
./
I.
VIBRATION
231112
./
TL with face 6 down "' 1108-Ll x W X H X 0.0035

TL = 1108-4 lx 3.5 X 2.25 X 0.0035
3
Calculated TL is rounded uo to next 5 lb. increment
30 Minutes with Fec:e I down @ O.A llnM
M brltion Table
3
!?
IIITEIIIIn
DROP
INDIVIDUAL
PACKAGE
18
108
0.0035
Shipping wt. (lbl.):
SHOCK
.l
it
-"'---
-w
/
\/
>'J
-~
..,......
.\ 7
./
\/
im"-'
~
ft1)rh
PPW~Cl/ pkg. description photos to be taken after ISTA testing is complete.

Photo of shlpper/contalner (Including ones wldillerent dimensions)
W1ll
FDm1 18230.()2
RevrewedBy
/}}t1L
CONFIDENTIAL
Date
~~;1uH~ I 3
Page 1 of 1
44
Control: 0.536 G nns

Demand: 0.528 G nns - 100.0%
TestQ 10: ISTA 3A

Profile ID: ISTA 3A Over-the-Road 1 Hour
Ch 1
1:52:08 PM
Jun-04-2013
ISTA 3A
C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_13-52-09.DRN
Control & Input Data
Elapsed: 1 hr 0 min 1 sec

Remaining : 0 hr o min 0 sec
=
-
Profile: 1 of 1
Total : 0 hr 0 min o sec
r-
0.1
0.01
~/
PSD
(G 2 /Hz)
0.0001
1\
I\
~
1-
r11r-
0.001
I \
\!\ :\~
~/
-;-
1\
I \
ll,_\
\
1\
:\'
1e-005 f=
'
1
\
,__
,__
'I
=
,__
1--
1-'-
1e-006
1-1--
1-
1e-007
10
20
Frequency (Hz)
100
200
Medium Vibration Table

Company Name: Bausch & Lomb -1304158
Orientation: Face 3
CONFIDENTIAL
45
ISTA3A
C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_14-40-01 .DRN
TestQ 10: ISTA 3A

Profile 10: ISTA 3A Over-the-Road 30 min
Ch 1
Control: 0.546 G nns

Demand: 0.528 G nns- 100.0%
2:40:01 PM
Jun-04-2013
Elapsed: o hr 30 min o sec

Remaining: 0 hr 0 min o sec
=
=
Profile: 1 of 1
Total: 0 hr 0 min o sec
0.1
0.01
~/
1\
--
PSD
(G 2/Hz)
0.0001
0.001
~/
I \
!\
v
'
1\
--
1!\
i\
I \
rrr-
1\
'\
1\ \
1-
f=
I
.
f-
1e-005
1/
rrr-
1e-006
r~
11-
1e-007
10
20
Frequency (Hz)
100
200

Orientation: Face 4
CONFIDENTIAL
46
TestQ 10: ISTA 3A

Profile 10: ISTA 3A Over-the-Road 30 min
Ch 1
3:18:22 PM
Jun-04-2013
ISTA3A
C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_15-18-22.DRN

Remaining: 0 hr 0 min 0 sec
Control: 0.534 G rms

Demand: 0.528 G rms- 100.0%
=
;:::
Profile: 1 of 1
Total: 0 hr 0 min 0 sec
c-
rr-
0.1
0.01
f=
~/
~
-
\
I
0.001
PSD
(G 2/Hz)
0.0001
~/
1\
I\
I\
[1
\1!\
\
1\
~
\
I \
r-
1\.\
\
1\l
1\
~
~
1e-005
1---
r=
r-
r~
1-
1e-006
I=
t-
r-
r-
t-
1e-007
10
20
Frequency (Hz)
100
200

Orientation: Face 6
CONFIDENTIAL
47

Remaining: 0 hr o min o sec
TestQ 10: ISTA 3A

Control: 0.464 G rms
Profile 10: ISTA 3A Pick-Up and Delivery 30 M1 Demand: 0.458 G rms- 100.0%
Ch 1
4:13:27 PM
Jun-04-2013
ISTA 3A
C:\TIV2\DmdProRnd\ISTA 3A_Auto5ave_2013-06-04_16-13-27 .DRN
Profile: 1 of 1
Total: 0 hr 0 min o sec
I=
ft-
0.1 t=
-
1/
\\
0.01
~
.....
r.....
1-
ff-
PSD
(G 2 /Hz)
0.001
t---
\~
1/
I
I
f-
f-
1I
f-
0.0001
/t
1f-
!\
f=
1\
f-
ff-
1/
1e-005 c--
=
-
1e-006
10
20
200
100
Frequency (Hz)
Orientation: Face 3 - 2
CONFIDENTIAL
,-
48
APPENDIX C: BUBBLE LEAK DATA
I Report No. I
DOL Inc
DOL West
R1304158-01-00
Customer:
10200 Valley View Road, Su1te 101

17371 Mount Wynne Circle, Suite A
Bausch & Lomb

Eden Prame MN 55344
Fountain Valley CA 92708
CONFIDENTIAL
Tel. 952-941-9226
Tel 714-979-1712
Page 17 of 17
Fax 952 941-9318
Fax 714 979-1721
49
Post EC/ISTA 3A
Bubble Leak Test
Cold
Tested and Proven
DOL Job N:
Customer:
PO N:
Product Name:
B&L Protocol:
Package Type:
Package Tested:
1304158
Bausch & Lomb
NA
BLP9490, Rev. A
Single Barrier Tray
Tray w/Tyvek Lid
o ,-kshee"t App,-oval .
Tes-t Technician
Machine Parameters
Flow Rate :
Pressure : CJ
Pressure Verification :
/&O
DOL SOP#: 6047

Tes7'-t-=-st:-a-nd7 a-r-:-d:-ASTM F 2096-11
0-
t{2{l~
A/
Spec1men
235498
"Dia. Gauge
Was Blocking Agent Used:

Yes or @circle one )
235499
Bubble Failure Locations

Tyvek Side Up.
A
B
Reviewed By:_ _,_,flth;:........,:::....__ _
(J~~--:-;:-""-"'!.-fE:d-::-:---
T e s1 D a"te s
PM (ino"toals)
Equipment Used: Pressure Delivery System

Asset#:
00
I
Cal Due Date:
// - ;-~ b - /~
Pressure Gauge
Asset #:
0 () ;;;_~to
Ca l Due Date:
\S- t{t:7V- ! 3
Notes
Sample Prep C
-'~'"""'~--'~~~~'
Sample
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
...!:::::: !Pass
Pass
~ 'Pass
2 Pass
--.;;;;Pass
1::::: Pass
~ Pass
~ Pass
~ Pass
-=:.:: rPass
-v Pass
~ Pass
~ Pass
....1.::::::: Pass
o/ Pass
Pass
17'" Pass
!2 Pass
~
Pass
l
l
I
I
1
'
PSI
CN
Rei#:
Resu lts
~ Pass
0 !]?12 ~
/G
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Comments/Location of Leak
(D
pkg test
photo V"
I
I
I
pkg des.
photo~
I
I
I
I
I
I
C>r /
uI
I
\"'i- /
I
_)
l)
,.z,
Joo., , ,
l !.tY
I I -' \
IYV
I
I
Date:
page 1 of 1
Form# 8105-06
CONFIDENTIAL
50
Post ECIIST A 3A
Bubble Leak Test
Hot
Tested and Pronn.
DOL Job N:
Customer:
PO N:
Product Name:
B&L Protocol:
Package Type:
Package Tested:
1304158
Bausch & Lomb
NA
BLP9490, Rev. A
Single Barrier Tray
Tray w/Tyvek Lid
Tes-t Techn1c1an :
Test Da-tes
DOL SOP#: 6047

Tes..::t-=-st-=-a-nd-=-a-r-=-d:- ASTM F 2096-11
(j
c{)O<fJ
Spec1men
235501
"Dia. Gauge
Was Blocking Agent Used:

Yes or @circle one)
235502
Bubble Failure Locations
Tyvek Side Up.
Reviewed By:_ _+-/f7hc~-U-..___ _
Date:
Sample
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Results
F"ass
Pass
Pass
......... Pass
~ [Pass
..00::::::::: Pass
~ Pass
Pass
-v Pass
~ Pass
12: Pass
-v: Pass
~
Pass
J2. Pass
Pass
.....,.
Pass
E Pass
~ Pass
:12" Pass
:-12"": Pass
\...
:z
\l l"Q "l/.>
fOote)
..::CN
~'"---.----
4- ](AN\..-/'}J/ 6u""-"' -/)

CE""'ndJ
(SCal)
.6d.PHD-
Machine Parameters
,r.. /Jn " I'
Flow Rate:
u ( .._,v-Pressure : ~or~-=:.
/~,.,...'--=-ps=-=1,.--
aI
CM
__
PM (inl1ials) .
Equipment Used: Pressure Delivery System

Asset#:
06(0
Cal Due Date: --11.;;,.--,E=-e..
-b~---:/,....,.lf-,:-Pressure Gauge
Asset #:
60 ,2. 8;- I 0
Cal Due Date: --5==---_....,)./(j-=;;;..v...,-~1-=--...3-
Notes
Sample Prep
~
~
Workshee-t Approval :
Pressure Verification : _---~o..C-.!..N.:L----
Rei#:
_0_~-1
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
Fail
pkg test
CommentsfLocation of Leak
photo~
((,
~
I
I
pkg des.
photo_
..
I
I
I
,
I
I
ft"'
./'1
I
I
AY
I IO V
'
.L
I
'
I
./
1\.
'
I' N
'-,1K11 -! ">
page 1 of 1
Form# 8105-06
CONFIDENTIAL
51
DDL
Tested and proven.
Vision Statement
DOL will become the preferred worldwide supplier of professional services in its chosen
areas of product, package and material testing , design and consulting .
Mission Statement
To continually strive to exceed our customer satisfaction by providing accurate data,
attention to detail and quick turn-around times by using DOL's quality system , responsive
project management and exceptional customer service.
DOL, 'IV..::r
17371 MI. Wynne Circle, Suite A
Fountain Valley, CA 92708
tel: 714.979.1712 1800.229.4235
fax: 714.979.1721
DOL, '7......
10200 Valley View Road, Suite 101
tel: 952.941.9226 1 800.229.4235
fax: 952.941 .9318
www.testedandproven .com
CONFIDENTIAL
52
B L

Revision: A
Page 50 of 63
CONFIDENTIAL
53

Revision: A
Page 13 of 15
Attachment 3
Visual Inspection
Cold Temperature Condition
Hot Temperature Condition

Sample
1
Pass (P) I
Fail (F)
Sample
Comments
Pass (P) I
Fail (F)
('
vf~
I \
1>
?
1>
\>
10
10
-p
Comments
'0
\
Yl{q
\
\
\)
Acceptance Criteria: Refer to section 12.0 of this protocol .

Comments: _ __.~----------------------
Performed By I Date:
Verification Results:
CONFIDENTIAL
54
B L

Revision: A
Page 52 of 63
Attachment 5- Lens Delivery
CONFIDENTIAL
55
Title: Reusable Injector Handpiece Ship Test

Revision: A
Page 20 of 20
Attachment 5
Functional lens Delivery
ow
1-
' 1S:
rr l,
"'<)~
Sample
Pass (P) I
Fail (F)
'
Lens
Diopter
Handpiece
Serial#
ttv. o
A-6ou62.
)>
--t-ro .o
Auc.v8C>
f(().
Aouv e5"
C)
t-
1'0
~T... _,
.He' =l=em.,eratttre eoudition
t-r.S
.....
___ , - ,.,----
Pass (P) I
Fail (F)
Lens
Diopter
31
'f
+'?>4"
AOD08'2.
32
7>
-+ ~'fo
Ae1uueo
33
'P
-\- 3Jf. 0
A-ovo~
34
p
-p
.f ~'/-0
ArJUo5q
t 3'"1 0
Aoov ;=f (
Sample
Handpiece
Serial#
(>
+ro .o
A-vou5Jf
(>
-t-r Q . o
kvo::f(
'P
-+ro . u
_A:_vo o '86
36
.f lj'f C)
Auo0B'6
'P
+fO . d
tfuuu
5e
37
f3'f.v
AovvS 8
+ro .u
AGI'oo
q~
38
P>
--t ~Lf.o
_A-c.vu;::;-&.r
+-r o.u
Aooo'S''J
39
.lf CJ
A-uu -:ls r
\->
+to . .::
,Ac;)ol..)3
40
-f
5'-f c)
Av<.>O'e3
10
35 ~
-:f-
/I"'Wr'er/1'1 lf"'S-# 3219-3!!>002.

t:l"d (Jit-7.> ovn~ ~d(. {1~ ..lflte
c>6~ ...vt"c:/ .
ovn v'J.<!
Acceptance Criteria: Refer to section 12.0 of this protocol.

Comments:
11d
.lx-
Ho!.Vl'lll'~ ,
's
c/eftwved
/~<fd
t--ep/fe:i>d
r~~5'~d
01d
wt:{t,
.v.d
rx'"'"'
~~-- ~
.:.t.s .. r...ved ,
k-7>
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/e't.S
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~...
fe.,t.J'
.fit
J-U!.W
c#(r'vp~d.
de.(t v~w;J
jN<>.S
s/,.;.1/
~ Pass
s;~?o608 orq
cfo/ivrt-.., _
[ ] Fail
CONFIDENTIAL
1~7..f
~"&A>.f
sW/ 6e
!>#1'" '7"k
Performed By I Date: --Jr-..,.::~

~V_0_
1/__;~
;..__ _ _ __
LJ(;J
,/
56
<.v<O.S
1./-J/-..re~
BAUSCH
LOCATION:
LOMB~
BLP9489
TYPE:
Deviation Form
TITLE:
Aliso Viejo, CA
IREV.
NUMBER:
I PAGE 1 OF I
Reusable Injector Handpiece Ship Test
DEVIATION FORM
This form is to be used to document deviation(s) noted during the execution of the protocol. Duplicate as required. A
separate form is to be used to address each deviation. Other details may be attached if necessary.
Deviation No.: 001
Protocol Section No.: 11 .1
Page No.: nla
PROTOCOL REQUIRMENTS
State the protocol requirements:
Per the Reusable IOL Delivery System DFU:
"Rotate the handpiece knob clockwise to advance the plunger. Ensure that the plunger tip engages the lens and remains
behind the lens throughout the entire delivery until the lens is fully released into the eye."
DEVIATION
Describe the deviation:
During the functional lens delivery section of the 'Post Ship Test Inspection', plunger tip override was observed on lens
sample #35 (serial number: 3217315002). The plunger tip rode on top of the lens optic approximately 0.5 to 1.0 mm but
was able to advance and exit the lens from the inserter with the plunger tip over the lens optic. However per the DFU, the
user is to ensure that the plunger remains behind the lens until the lens fully exits the inserter tip.
Documented By:
Will Sea
Date: 12-Jun-2013
DEVIATION RESOLUTION
0 No corrective action required; justification explained below or attached.

181 Corrective action required:
D Documentation correction only
181 Retest item
D Retest section(s)
D Protocol Addendum required

Justification or corrective action to be implemented:
Lens #35 (serial number: 3217315002) was inspected for cosmetics immediately after delivery which showed the optic
edge to have an imprint mark in the area that the plunger tip contacted. After 18 hours at room temperature, the lens was
allowed to relax to it's original properties and the imprint mark was no longer present rendering the lens acceptable per
FP-3243. Note that per ISO 11979-3:2006 Section 5: "After release from the deformed state, allow the lens to relax at in
situ conditions up to 24 h 2 h."
Prepared By I Date:
I Approved By I Date: Troy Painton
Will Sea
d /'/
_ / //
/2;/(lfo/2-0f_S
SUMMARY OF CORRECTION ACTION

Due to lens #35 (serial number: 3217315002) not remaining in front of the plunger tip during lens delivery, the sample
was not used as part of the functional delivery testing data and was replaced with lens serial number 3350608019 and
retested. The operator ensured that the plunger tip remained behind the lens during the delivery and the post-cosmetic
delivery acceptance criteria was met.
Acceptance Criteria Met?:
181 Yes
Approved By I Date: Troy Painton

Approved By I Date:
DNa
4~
...
(Z.:JvCU"Zo\,l'
CONFIDENTIAL
57
AVC Surgical Testing Laboratory
TP-8261 I Functional Delivery Testing
BAUSCH + LOMB
TO D..,.:!' ..
c,,--a.:---t 1""\-r:
--."T'--a.:--
l A - : __ - - \
See better_ Live better
1-"'' -
CONFIDENTIAL
58
r---
ISO 11979-3 I 4.12 - Surface and Bulk Homogeneity (Cosmetics)

Test Set-up
~ails
BLP9489
lll'JiiOCOIHNumber
IT:esttRoint
Ship Study
rs a1ii{ile r/D
Amvisc Plus
enVista MX60
'l !effiilMDiliill
.I
FP Spec./ Rev
t==?- 2 4-.!. g
Protocol
Completed By:
E"qui~ment Details
'Microscobe ID
EO- CJS"C:.
Gauge<BIO]ik ID
~ ~ 7 2..3 G
GililifiitilfiiiJD_ue
0 f_ .2 J_ A L/!&ht lletif ID
c.ooooR.
0 CillliiiiJJQfflDJi8LJ
7-2-6- -4-z,
(jfpj___.--
k.11A-u '-! ,p l.J /Jryl
Print I Sign'
Parameter
"G.Oiiilitloro
-:J
=-
MiiifjifiCiltiOifL__
'INg/jtl/ifteniifYJ
S~ifieac=J L
As Specified
1Ox (for set-up)
3,800 350 FC
:=1rciiii1~
'R ~S
to "'~-
!,_, g6 -;-
~ ~
!J - I n
Test Details
Date
- --
Test Execution (PRE Functional Delivery)

Sample
IOL Serial .#t'
Jl..ow)
14
3344962036
3344963012
3344963006
3344963009
3344963013
3344962041
3344962038
3344962039
3344962037
3350122002
n/a
n/a
n/a
n/a
CJ1~5D
nla
c:31c:::::J
2
c:::;3"LJ
i4LJ
5
6
7.c=J
c:=rac
~9CJ
l__j1:ao
Pass/
fail
'f'&tSS
t 51D
12
c:::=:J1:a0
References:
FP-3216
FP-3219
FP-3243
BLR7989
Sample
(Mfd)
16
P~l~ C31r7D
_f:>taH L31.8LJ
C319D
Po._t~
Pa..s~
0 200
?ASS
PIA~ S
21
c:::.r220
23
24
'PAl.S
'Pal~
P~>ls
0250
1\
I
26
'
CJ271
28
29
I
.,, ~
30
[.:.io~~ ~ l
n/a
n/a
n/a
nla
n/a
n/a
Pass/
I=ail
Sample
(flgh)
r..
\'
\
\
t1{~
nla
~37.]
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
31
32
33L
34
35
36
38
39
\ L1J.a'J
L ~j1[l
42
43
IOLSerial@
3343748012
3343748014
3343746016
3219316009
-3217815992 it'3219316016
3343749020
3219316017
3219316008
3219316005
n/a
n/a
nla
nla
44
45
n/a
Pass/
Fail
EA ~_s..
Completed By
Print I Sign / Date
I(..W.A-o-11.\
'
Pl.4.4-~'-""
P IA'H
?as~
"1=>-'li'i
b- AO _,!.
Pa s.s
f'Gl~>
~at.S
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Pt;'u
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\
n/&.
\
\J
"33506o5 o l~
Akreos Global Cosmetic Inspection Criteria

Silicone IOL Cosmetic Criteria
enVista Lenses Global Cosmetic Criteria
Installation Qualification for the Cosmetic Inspection Microscope System
Acceptance Crieria Met

)!(
_L
NO
0
I
YES
Check One
RmewedBy:
~q
/o-i~~
BAUSCH + LOMB
TP- R?R1 ... l=unl"tinn:al r\oli\fanr TOC!t inn /Arnu5e-"" Char-\
/17n\ vl ... v
" - - - , . , -6 Co
CONFIDENTIAL
See better. live better.
59
......
Functional Delivery Testing
Completed By:
Test Execution
:
H.c..,Jputt>
Sample
.$(1rlal<#-
Ao"'o <o'{-2.
/r<~uo
f,o
ftvtJO ~ 5""
Aocl o
?'t
(Low)
'
1
L_l2r=J
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;;e
5
6
7_
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AcJCJO
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b\!t.l\,;
IOL Serial ,#
.1
r=I9r=J
C31:00
C'l1fi1C
12
13
c::3t~D
15
I
3344962036
3344963012
3344963006
3344963009
3344963013
3344962041
3344962038
3344962039
3344962037
3350122002
n/a
n/a
n/a
n/a
n/a
Labeled ,
Fold
Unfold
lfa@
IDJ
fHR:MiNJ
tHi:i:MINJ
-tro .o
n/a
n/a
n/a
n/a
n/a
n/a
n/a
nla
n/a
n/a
-t"(o.o
nla
-T(o. u
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
nla
nla
nla
nla
nla
nla
f:>~,rr
n/a
n/a
pq~
~o. o
-+ f0 -0
-t ro.o
.+ ro.o
t-( cJ . o
HO. <J
-t WO
<\1
..,;,
'I
\V
Fold
Duration
(MtNJ
n/a
nla
n/a
n/a
n/a
n/a
nla
nla
n/a
n/a
nla
nla
nla
nla
nla
Delivery Outcome
(Pass I Fail)
?d15'
'?-?!>
~$
?et.3
7'.... ~
?'..,>>
li>,.rs
n/a
n/a
n/a
J>~)
(j)
~
~r
I
\)'
S1ring
Count
(#J
n/a
n/a
n/a
nla
nla
Injector Cosmetics
(Pass/FaN)
% ff
. e..!}>
.Rl~
'?.:$5'
?~
nla
~r
n/a
n/a
n/a
n/a
n/a
n/a
n/a
nla
n/a
?A.;>
?mr
~- ~~
Print I Sign I Date
~M.
C~"J:
w~ ..;,::;,"~
<P.A-iV
Cvrd
f.-tor
D6 ~ f 0 - I?
~~.>
~r:>
(,\
j
nr~
I
U'
TP-8261 IOL and Insertion Device Fold & Recovery and Functional Delivery Testing
FP-3242 IOL and Insertion Device Fold & Recovery and Functional Delivery Criteria
){.
YES
I
NO
0
I
References:
Check One
BAUSCH + LOMB
TP-A?R1 .. t=rrnl"tinn:al nAihiDnl TDetinn lA mule,.. Plt.e\ /170\ vlr-v
c~ ... ,.. 6'l ""''~
CONFIDENTIAL
See better. Live better.
60
('"\
Completed By:
Test Execution
r ~=k!l.
IOL Serial#
16
17
18'
19
n/a
n/a
n/a
nla
- Labeled
Power
fDJ
0 200
nla
21
,22
u 2au
24
25
0 260
n/a
nla
:\
Fold
Start
Unfold
fHR:MINJ
fHR:MINJ
nla
n/a
n/a
nla
nla
n/a
n/a
n/a
n/a
nla
nla
nla
t1141
nla
n/a
n/a
n/a
n/a
n/a
n/a
nla
0~70
nla
280
29
n/a
n/a
~3QC_]
nla
nla
nla
\1.
nla
Sbing
Fold
~ Cosmetics
~Outcome
Duration
(Pass/FaD)
(Pass I Fall)
, ~
(#)
(M/NJ
nla
nla
r
\
nla
nla
n/a
n/a
nla
n/a
n/a
n/a
nla
n/a
nla
n/a
nla
nla
nla
nla
nla
nla
n/a
n/a
nla
n/4
n/a
n/a
nla
n/a
n/a
n/a
n/a
nla
~
J
h/1
~
nla
n/a
nla
n/a
n/a
nla
'/
Print I Sign I Date
()6 - t l( - 1 ~
nla
nla
nla
nla
Completedhl
ct
Acceptance Crleria Met
~
YES
I
~
RevlewedBy:
NO
0
I
References:
Check One
TD DI')C ..
e .. --A: ---1
M-1 :. . - - . T - -! - -
l A - . .: _ _
r-11
.- ~
,,._,.. ~
_____:-;
~
/
--------
._
Sign
/c--::r... -:;~-~
Date
BAUSCH + LOMB
c;,.,. hPthr I iv,. hPttPr
CONFIDENTIAL
61
~""'

Protocol_Deteils
i'RiOfocoliNumber
rT.Ntjl!iJinrcsaif11!1ii]ID1
'Lens Jloiliil
im.SJ:Jec.l Rev
Iii!SPec. I Rev
- -
BLP9489
Ship Study
Amvisc Plus
enVista MX60
TP-8261 I Rev C
FP-3242/ Rev B
- -
Completed By:
Test Set-up
Equipment Details
ITiimerl S/N[ ~
J
.-?.!.?
In/ector_~
Date
c~
Print / Sign
COtrditlon
Fold Time
Ak-.X. I
! "5"61I 2._Ao{
hltf
Viscoelastic
Viscoelastic Lot#
Visco. E1gJ. Date
tM~N
Parameter
11~
Calibration Due
Injector Model
tl!!lector Lot#
T~tDetails
Specified
Actual
per Protocol or~ '8/35 Pi' ~c.
~ 3min s 20 min
n/a
~a/
/1.
l')2.-i'2~ Z..
z-tct -o '=!-
[)6 -!(f) -1Y>

-
Date
Test Execution
H"""f,.,_IR
~
(High) I ,
$e.1.4ol ~
Aoe~o~-z..
,4-0CIO
B"
J4-0vV 5"1
A-ooo71
1'\cJ"" ~&
,Aa <Jv
;-e
ft<iCIO
=1/f
I
I
I
33
34
35
36
37
0 380
A- e1oo'S'1
C]39'D
,46voe3
CI4t:lD
0 4i'ID
42
c::I43D
I
J:~L
Serial
(D)
3343748012
3343748014
3343746016
3219316009
3110
0 320
rtuuu55"
IOL
Labeled
I Power
45
i-3+U
~ ?.Y.o
+ ~u
~
>lf, C
3211816QQ2 If
+~If.()
3219316016
3343749020
3219316017
3219316008
3219316005
n/a
nla
n/a
nla
nla
-B.If.u
B'fo
-~
.-
-+3~. 0
-+ >lf-CJ
4- ~.if. C)
"'J
Vl(q
v
---
Fold
Unfold
Time
Fold
Duration
(HR:MINJ
(MINJ
nla
n/a
n/a
n/a
nla
n/a
n/a
n/a
n/a
nla
n/a
nla
n/a
nla
nla
n/a
n/a
n/a
nla
nla
nla
nla
nla
n/a
nla
n/a
n/a
nla
nla
nla
lHR:MiNJ
n/a
n/a
n/a
n/a
nla
n/a
nla
n/a
n/a
nla
nla
n/a
nla
n/a
n/a
Delivery~
(Pass / Fall)
-
":>~
~r'>
R>JS
p~.s
?~
~
{?.>
~.F5
?'5"
P'J')
"l
I
~
I
\J....
String
Count
(I),
F~~
(Pass I Fall)
.:v~
?n-.r
nla
n/a
n/a
n/a
n/a
nla
n/a
nla
nla
nla
nla
nla
nla
nla
nla
.f.?rrr
-~
~?'$"
Completed By
Print I Sign I Date
(!..~(?
CG
f-l~ TP--11--rJ
~~
1'6 --I 0
D;!cf
t?
. tffxr
~-
'
~;>'"
/-(of
2.$'S"
~.P.S
..,
(
ill~
J.,
)..
YES
I
NO
D
I
Reviewed By:
References:
Check One
J--~
----.
~
/
S1 n
,/0-U'<----:.31
Date
BAUSCH + LOMB
TP.A?~1
_ l='tai"U't lnn!!lll r\alh1an 1 Tt!llf"ti n,.. lA_,,; ,.." Dlo 1"\ 117n\ ..,,.,._
"'---,... -1,..
CONFIDENTIAL
62
ISO 11979-3 I 4.12- Surface and Bulk Homogeneity (Cosmetics)
Completed By:
Test Execution (POST Functional Delivery)
~l
~1C":J
2
3
4
5
c=I6U
c::Jr7t=l
8
9
10
01~10
0 1'20
c=5f3D
14
15
IOL !~,#
"[D!j
ean
Po~us
3344962036
3344963012
3344963006
3344963009
3344963013
3344962041
3344962038
3344962039
3344962037
3350122002
n/a
n/a
Pe~lc;.
Pa~
_E>Q_.s_..s
P~u~
Sample
(Mkl}
1:6---=:J
17
~tao
L 3l9L 1
[_1200
Po~s
21
f'a.H
0 22L
'P~H
Pros
A::ljj
nla
nla
231
24
250
26
27
28
29
D r:J
n/a
~LSeriaiJ
Pass/
Fail
n/a
Sample
{1-fgh)
nla
n/a
n/a
n/a
n/a
n/a
n/a
n/a
nla
3J1D
32
33 .
34
.35
nit<
n/a
\ll
til
nla
n/a
n/a
n/a
WA
36
[_l3l1'C
38
39
40
C 7 4JiCl
42
43
44
450
.. ,,. .
IOL{SHru#
3343748012
3343748014
3343746016
3219316009
-9217'S~5992
1P~
Print / Sign / Date
f>t::\~S.
'PetS.~
lc.IIA-"'1-4
PIIA~
Pa~s
Pel~5
f _-=
3219316016
3343749020
3219316017
3219316008
3219316005
n/a
n/a
n/a
n/a
n/a
-*"
Completed By
JF.iill.
Pa.s~~
6 . 10
.11]
' * 6/t.ft~
WS"
1't~.)S
PtuC.
VtiS\
_1:>(;'tS.
~
I
111M
L
11:1 .
5d-pk 3-~ v~pf,tpJ. ""/ sj,AI : -a?-5"060 Sol"l 01-(.L -lu /e .. s owvvo.k.
Akreos Global Cosmetic Inspection Criteria
/:-1-- -the. 'l>F-U '
;/
"Jt,p y , d ..s De,'{'-- ;~,s o;:r/'c
Silicone IOL Cosmetic Criteria
s-/rJp If'" t:/d n4/ c:/~RV"'- '7'k (ehS .
enVista Lenses Global Cosmetic Criteria
Installation Qualification for the Cosmetic Inspection Microscope System
1[ --:35"""=-="=""f""'"
1}
!3.-::3. -:=
5"::-::0~
6-:tJ-::::~:-o~/""""
C,_,.:-r
t -;:R:;-~--:-~-:? -,t
YES
I
X.
References:
NO
FP-3216
FP-3219
FP-3243
BLR7989
Check One
rt-r....
't- ,_t" "
ReviewedBy:
~
Sn
/O-:J~---;.,~ 1
~~
BAUSCH + LOMB
TP. R?R1 -
~unl"tinn~l r1aliuant Ta~t i nn
IA'"utro,..
Diu~ \ 117n\ vl~v
CONFIDENTIAL
63
B+ L
I Revision:
I Page 61 of 63
CONFIDENTIAL
64
Page 14 of 15
Revision : A
Attachment 4
Bubble leak - Post Transit Data Sheet
Temperature Condition:
-lO!!C 2!!C with uncontrolled RH
60!!C 2!!C with 85% 5% RH
Sample
Pass (P) I Fail (F)
'P
rp
7
'P
'P
'P
9
10
Comments
Sample
1
~/A
Pass (P) I Fail (F)
l'
rV/4-
N!A
-tJ Jtr
/I)/A
tV/It
Comments
,J~
/VIA
tV/h
f
p
-p
II/A
#/h
lf//1}
tJ/4
:p
11/11
A)/A-
'P
IJ)It
1'
r/JP-
10
:p
p
"-P
AJ/11
)1/IJ
rV llr

Comments: _ _ _ _ _ _ _ ___.~~--------------
Performed By I Date: _
_......LAJ~i-4----'tQ"'---...:.j~U:.:.:n..:..-......1..::;~--lir'ass
[ ] Fail
CONFIDENTIAL
65
Page 15 of 15
Revision : A
Bubble leak- Post Transit Data Sheet

-102C 22C with uncontrolled RH
602C 22C with 85% 5% RH
Sample
Pass (P) I Fail (F)
Comments
Sample
Pass (P) I Fail (F)
Comments
11
:p
tV/A
11
12
f>
IV/A
12
13
f
p
p
AJJA.
13
I>
AJ/4
#/JJ
14
!VIA-
#lA
111111
15
dJ!t
16
p
p
N/A
AIJJJ
#LA
r/111
!'1/ll
17
':p
AliA
18
fliL4
19
'P
111/~
20
14
15
16
17
f
'P
18
19
1'
20
=r
t>
'P
tV/11
til~
d/11

Comments: _ _ _ _ _ _ _ _~AI;,..cll;.;.'ll-.:......._ _ _ _ _ _ _ _ _ _ _ _ __
Performed By I Date:
C/1)
~ass
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CONFIDENTIAL
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Rochester, NV

Ship Test Protocol
BLP9490
/~(l*f![zog
Prepared By:
Troy Painton
Approval Signatures I Dates

Date:
Global Packaging Manager: Brian B xton .
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Date:
Date:
Date:
EMO: Randy Woods
Date:
Date:
Date:
Date:
CONFIDENTIAL
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Title: Reusable Injector Cartridge Ship Teet
Revlelon: A
Pqe 1 of 15
A
Rochester, NY

Ship Test Protocol
BLP9490
Prepared By:
d~(-*A(zotf
Troy Pointon
Date:
Date: /tfDate:
EMO: Randy Woods
Date:
Global Quality:
Date:
5ft
Date: /(,
Medlcel: Tobias Maler
Date:
CONFIDENTIAL
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I Page 1 of 15
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Rochester, NV

Ship Test Protocol
BLP9490
Prepared By:
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Troy Pointon
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Date:
Date:
Date:
Date:
EMO: Randy
Wood~_ ~A
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Date:
Global Quality: Sanaz S~tode~
Date:
Date:
Date:
CONFIDENTIAL
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Page 1 of 15

Rochester, NV

Ship Test Protocol
BLP9490
Prepared B y : - - - - - - - - - - Troy Pointon
Date:
Date:
Date:
Date:
EMO: Randy Woods
Date:
Date:

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Date:
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CONFIDENTIAL
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Table of Contents
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
INTRODUCTION
PURPOSE
SCOPE
REFERENCES
RESPONSIBILITIES
TEST PROCEDURE
ACCEPTANCE CRITERIA
PRODUCTION DISPOSITION
ATTACHMENTS
CONFIDENTIAL
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4
4
4
4
5
5
5
6
6
9
9
9
10
10
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REVISION HISTORY
Revision
No.
Revision History
Original Document
CONFIDENTIAL
Author
Date
T. Painton
5/16/2013
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INTRODUCTION
This protocol will evaluate the proposed packaging configuration for the AX-Xl reusable injector
cartridges for Project ROSOl ability to withstand the anticipated distribution hazards.
2.0
PURPOSE
This transportation test will provide documented evidence the reusable injector cartridge packaging
configuration protects the product when exposed to the hazards of normal handling, storage and
distribution per ISTA 3A standard .
This transportation test will provide documented evidence of compliance with applicable IS0-116071:2009 requirements.
3.0
SCOPE
This verification is limited to the AX-Xl reusable injector cartridges being developed under B&L Project
ROSOl. Cartridges are manufactured and packaged at Medicel.
4.0

Description
Name
AVC
B&L
oc
DOL
ISTA
N/A
No. or#
P/N
PC
RH
SOP
%
5.0

Bausch and Lomb
Celsius (in degrees)
Distribution Dynamic Labs
International Safe Transit Association
Not Applicable
Number
Part Number
Procedural Choice
Relative Humidity
Standard Operational Procedure
Percent
REFERENCES
Document #/Rev
ASTM F2096-11
Viscoject l.S Cartridge
Document Title
Detecting Gross Leaks in Packaging by Internal Pressurization
(Bubble Test)
Cartridge
Cartridge
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Document #/Rev
Document Title
Packaged-Products for Parcel Delivery System Shipment 70kg
{1501b) or less
enVista MX60 IOL
Ophthalmic implants-- Intraocular lenses
ISTA 3A-2008
FP-3244, Rev F
ISO 11979-5:2006
6.0
RESPONSIBILITIES
Group
B&L Global Packaging
Medicel
B&LAVC
DOL- Testing
Laboratory
7.0
Page 5 of 15
Responsibilities
Writing the protocol and final summary report

Arranging for testing at the ship test facility
Test sample builds
Functional Lens Delivery
Subjecting test samples to the conditioning and test parameters
Returning test samples to B&L Aliso Viejo, CA

Training- Current Good Manufacturing Practices for Medical devices shall be followed throughout the
execution of the protocol. Operators will be trained and training will be documented in the training
form in this protocol and the applicable SOPs prior to performing their assigned tasks.
Process Equipment- No new computer systems or processing equipment are being implemented that
would require validation before the procedure in this protocol is executed. Measurement equipment
shall be appropriate for the attributes being measured and capable of providing meaningful and valid
results. Calibrated inspection equipment used during the execution of this protocol will be
documented in the final report.
Process Materials/Components- Materials and packaging components for this study will be
inspected, approved and released for use per standard Medicel procedures before they are utilized in
this study. The manufacturing plant will document all materials and components used in this study by
part number. Lot numbers for all components will be documented in the final report.
8.0
9.0
Sample size of six (6) cartons, sixty (60) cartridges in total, will be used to for this testing. Hot and cold
environmental conditioning will be conducted on three {3) carton test samples at each condition.
Functional lens delivery testing will be included as part of the acceptance criteria . Ten lenses will be
delivered for each environmental condition parameter to satisfy the minimum requirements of ISO
11979:2006. enVista MX60 lenses with various diopters will be used for functional lenses delivery. AXR1 Handpieces from BLP9489 will be used for lens delivery .Handpiece serial numbers will be recorded
in the lens delivery datasheets. Lenses delivery will be captured in BLP9489 datasheets and will be
included in BLP9490 report.
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The following procedures will be followed for protocol execution:

9.1
Build and package sixty (60) cartridges per Medicel control card Viscoject 1.8 and 2.2
Cartridge Set instructionsfor Axiom IOL Delivery System X1 Cartridge
9.2
Place packaged cartridge samples into over shipper. Label outside of shipper with BLP9490.
9.3
Ship test samples to test facility at the address below via expedited air I truck shipment:
DDL, Inc.
10200 Valley View Road, Suite #101
10.0
TEST PROCEDURE
The following procedures will be followed for protocol execution:
10.1
Upon receipt of test sample at the test facility, the test samples will be removed from its overpackaging and subjected to each of the following environmental conditions for no less than 72
hours.
#of Cartons
Test Condition
Cold
Hot
Temperature I RH
Duration
-10C 5 I Uncontrolled Relative

Humidity
Then
72 hours
I
J
48 hours
24 hours
The total time exposed will be included in the report from test laboratory.
10.2
Identification of test sample faces, corners, and edges:
4---y
5
10.3
Drop Sequence: 9 drops will be performed per ISTA 3A as indicated in the following:
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Random Vibration: Random vibration will be completed per ISTA 3A as indicated in the
following:
NOTE: No top load weight is required based on the top load calculations are less than 2Sibs.
FreqLncy
(!h)
PSD Level,
10
3.0
50
70
12.0
150
0.0007
0.02
002
0001
0 001
0004
24.0
280
36.0
420
75.0
2000
0.004
0001
0.001
0.003
0.003
0.000004
g'/Hz
IDO
10
Frequency, Hz.
10.5
Random Vibration : Random vibration will be completed per ISTA 3A as indicated in the
following :
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ISTA 3A Pick-up and Delivery Vehicle Spectrum

Freq.~ency
(Hz)
10
~0
.t.O
i .O
BO
15.0
:!tO
23.0
5).0
n.o
10.0
2(00
PSO Level,
g'/Hz
0.001
0035
0.035
00003
00003
0.001
0.001
00001
0.0001
0002
0002
0 00005
0.1
10.6
Drop Sequence: 8 drops will be performed per ISTA 3A as indicated in the following:
10.7
Upon completion of the ISTA 3A procedure, the 1 carton from each environmental
conditioning group will be overnight delivered to B&L:
Attention: Sushant Muchhala

Bausch + Lomb
30 Enterprise, Suite 450
Aliso Viejo, CA 92656
11.0
Remaining 2 cartons from each environmental conditioning group will be bubble leak tested
per ASTM F2096-11.
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The following evaluations will be executed post ship testing at B&L Aliso Viejo:
Product Inspection: Evaluate 10 cartridges (1 carton) from each temperature

condition. Visually inspect carton label legibility, carton, DFU, and sealed cartridge
packaging for damage under normal office lighting conditions. Document the results
in Attachment 3 datasheets.
Functional Lens Delivery: Following product inspection deliver 10 lenses, one per
cartridge, from each temperature condition. Verify dimensional acceptance per the
following:
Finished Product
Specification
Drawing Number
FP-3244
BL000024661,Rev.A
BL000024653,Rev.A
O.OD to +4.0D
+lO.OD to +34.0D
Results will be documented in BLP9489 Attachment 4 datasheet.

11.2
The following evaluations will be executed post ship testing at DDL:

Bubble Leak: Evaluate 20 cartridge trays (2 cartons) from each temperature condition .
Perform bubble leak testing per ASTM F2096-11. Verify no leaks occur. Document the
results in Attachment 5 datasheets.
12.0
13.0
ACCEPTANCE CRITERIA
Inspection
Test Reference
Sample Quantity
Product
Inspection
Visual
Functional
Lens Delivery
FP-3244
10 per Temperature
Condition (samples
will be used for both
tests)
Bubble Leak
ASTM F2096-11
20 per Temperature
Condition
Pass I Fail
Ace
Rej
Accept 0 I Reject 1
Accept 0 I Reject 1
0/1 of 20
PRODUCT DISPOSITION
The protocol manager will disposition all package samples produced and used for the purposes of this
study within three months after the summary report is completed and approved.
Product utilized for this study is for experimental purposes only and not for commercial use .
14.0
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In the event that differences occur between the protocol requirements and the protocol execution,
these differences will be addressed in a section of the Summary Report entitled "Deviations to the
Protocol". The impact that each deviation has on the protocol will be assessed and documented in this
section.
15.0
ATTACHMENTS
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LOM
BLP9490
BA
Employee Name (Print)
Training Record
Employee Signature
Employee ID
1
I
Instructor Name
Training Date
,
I
Date:
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Sample Preparation
Medicel will build test samples
!
Ship Testing
Environmental conditioning, vibration, and drop testing
will be conducted at DDl packaging test lab
Bubble Leak Testing

Bubble leak tested at
DDl packaging test lab
!
Test Sample Inspection
Visual inspection and functional lens delivery at
Bausch & lomb Aliso Viejo, CA
~
Generate Report
Global Packaging will generate a report
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Attachment 3
Visual Inspection

Sample
Pass (P) I
Fail (F)
Comments

Sample
10
10
Pass (P) I
Fail (F)
Comments

Comments= - - - - - - - - - - - - - - - - - - - - - - - - - - -
Performed By I Date: - - - - - - - - - - - - Verification Results:

[] Pass
[] Fail
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Attachment 4
Bubble Leak- Post Transit Data Sheet
Sample
Pass (P) I Fail (F)
Comments
Sample
10
10
Pass (P) I Fail (F)
Comments

Comments: - - - - - - - - - - - - - - - - - - - - - - - - - - -
Performed By I Date: - -- -- - - - - - - - Verification Results:

[] Pass
[] Fail
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Bubble Leak- Post Transit Data Sheet

Sample
Pass (P) I Fail (F)
Comments
Sample
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
20
20
Pass (P) I Fail (F)
Comments

Comments: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Performed By I Date: - - - - - - - - - - - - Verification Results:

Pass
Cl Fail
CJ
CONFIDENTIAL
84

7-3 BLR 9490 Cartridge Packaging Validation

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B+ L

Title: Reusable Injector Cartridge Ship Test

Document Number: BLR9490

Global Packaging Engineering

Reusable Injector Cartridge

Prep ared By: __

Approval Signatures I Dates

Project Manager: Sushant Muchhala

D&R Engineering: Will Sea

EMO: Randy Woods

Global Quality: Sanaz Sotodeh

Supplier Quality: Joe Melnick

Medicel: Tobias Maier

Reuuble Injector Cartridge Ship Test

Document Number: BLR9490

Global Packaging Engineering

Reusable Injector Cartridge

Project Manager: Sushant Muchhal

Global Packaging Manager: Brian Buxton

D&R Engineering: Will Seo

Global Quality: Sanaz Sotodeh

Supplier Quality: Joe Melnick

Medicel: Tobias Maier

Reusable Injector Cartridge Ship Test

Document Number: BLR9490

Global Packaging Engineering

Reusable Injector Cartridge

--~-t--~~-____.:..=z ~J z.~r~ .-e_ _

Project Manager: Sushant Muchhala

Global Packaging Manager: Brian Buxton

D&R Engineering: Will Seo

Global Regulatory Affairs: Jason Smith

Global Quality: Sanaz

Supplier Quality: Joe Melnick

Medicel: Tobias Maier

Title: Reusable Injector Cartridge Ship Test

Document Number: BLA9490

Global Packaging Engineering

Reusable Injector Cartridge

' ~-~pr-oval Signatures

Project Manager: Sushant Muchhala

Global Packaging Manager: Brian Buxton

D&R Engineering: Will Seo

Global Regulatory Affairs: Jason Smith

EMO: Randy Woods

Global Quality: Sanaz Sotodeh

Supplier Quality: Joe Melnick

Title: Reusable Injector Cartridge Ship Test

Title: Reusable Injector Cartridge Ship Test

Document Number: BLR9490

Title: Reusable Injector Cartridge Ship Test

DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

Title: Reusable Injector Cartridge Ship Test

Document Number: BLR9490

Detecting Gross Leaks in Packaging by Internal Pressurization

Wrote the protocol and final summary report

PRE-REQUISITES AND GENERAL REQUIREMENTS

Title: Reusable Injector Cartridge Ship Test

Document Number: BLR9490

SAMPLING PLAN AND RATIONALE

TEST SAMPLE PREPARATION

-10C 5 I Uncontrolled Relative

Title: Reusable Injector Cartridge Ship Test

Identification of test sample faces, corners, and edges: