>

CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 1 of 7
Component) for Vision Care

Purpose
This document provides return sample conditions, product evaluation results and the applicable IMDRF Codes for Annexes B, C, D
and G to assist the user in selecting the appropriate codes for Vision Care product complaints. Refer to
http://www.imdrf.org/working-groups/adverse-event-terminology for additional IMDRF codes.

Sample Condition Annex B Code and Description

Open B01 Testing of Actual Suspected Device
Sealed B03 Testing of Device from Same Lot/Batch Returned from User

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
Product Within Specification and Customer Use
9000 Product Within Specification C19 D14 G07001 C19 No Device Problem Found
9100 Damage/Torn Due to Customer Use C23 D11 G07001 C23 Usage Problem Identified
9101 Deposition Due to Customer Use C23 D11 G07001 D11 Cause Traced to User
9102 Discoloration Due to Customer Use C23 D11 G07001 D14 No Problem Detected/Cannot be Confirmed
9103 Product Different Than Specified C23 D11 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9104 Less Than ½ Lens/Dried Lens C23 D11 G07001
9106 No Product Returned in Container C19 D14 G07001
9107 Not a Bausch & Lomb Product C23 D11 G07001
9108 Foreign Material Due to Customer Use C23 D11 G07001
9109 Customer Altered Product C23 D11 G07001
9111 Insufficient Sample for Required Tests C19 D14 G07001
9900 Other/Describe C23 D11 G07001
Miscellaneous Defect
9901 Other Failure/Describe C16 D03 G07001 C16 Manufacturing Process Problem Identified
Cosmetic / Visual Categories D03 Cause Traced to Manufacturing
9202 Cloudy C16 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9209 Image, Poor C16 D03 G07001
9210 Irregular Edge, Rough C16 D03 G07001
9211 Irregular Edge, Unfill C16 D03 G07001
9212 Irregular Edge, Untrim C16 D03 G07001

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 2 of 7
Component) for Vision Care

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
9213 Irregular Surface, Bubble C16 D03 G07001
9214 Irregular Surface, Pit C16 D03 G07001
9215 Irregular Surface, Rough C16 D03 G07001
9217 Irregular Tint, Fade Out C16 D03 G07001
9219 Irregular Tint, Hue & Intensity C16 D03 G07001
9221 Lens Inverted C16 D03 G07001
9223 Poor/Incorrect Engraving C16 D03 G07001
9224 Poor Wettability C16 D03 G07001
9230 Laser Marks, Missing C16 D03 G07001
9233 Lathe Mark C16 D03 G07001
9234 Mold Marks C16 D03 G07001
9237 Out of Round C16 D03 G07001
9238 Polishing Marks/Swirls C16 D03 G07001
9240 Polymer Hump C16 D03 G07001
9241 Poor Center C16 D03 G07001
9245 Rolled Edge C16 D03 G07001
9246 Scratch C16 D03 G07001
9247 Stain C16 D03 G07001
9251 Worm Tracks C16 D03 G07001
9254 Unlathed Lens C16 D03 G07001
9258 Hole C16 D03 G07001
9259 Excess Material C16 D03 G07001
9261 Reverse Curl C16 D03 G07001
9263 Base Curve Image Poor C16 D03 G07001
9271 Center Combined C16 D03 G07001
9272 Center Dark C16 D03 G07001
9273 Center Light C16 D03 G07001
9274 Center String C16 D03 G07001
9275 Edge C16 D03 G07001
9276 Peripheral Dark C16 D03 G07001
9277 Peripheral Light C16 D03 G07001

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 3 of 7
Component) for Vision Care

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
9278 Peripheral String C16 D03 G07001
9279 Pit/BB Rectangle C16 D03 G07001
9280 Pit/BB Round C16 D03 G07001
9281 Aberration C16 D03 G07001
9282 Decentered Print Pattern C16 D03 G07001
9285 Uneven Print Pattern C16 D03 G07001
9286 Missing Print Pattern C16 D03 G07001
9287 Stray Print String C16 D03 G07001
9289 Print Pattern Off Color C16 D03 G07001
9292 Distorted Apex C16 D03 G07001
9293 Localized Optical Aberration C16 D03 G07001
9307 Piece of Material (POM) C16 D03 G07001
9308 Polyvinyl Alcohol (PVA) Precipitate C16 D03 G07001
9309 Chlorhexidine Gluconate (CHG) Precipitate C16 D03 G07001
9310 Glycerol Monostearate Suspension (GMS) C16 D03 G07001
9400 Folded C16 D03 G07001
9402 Nick C16 D03 G07001
9403 Puncture C16 D03 G07001
9405 Tear C16 D03 G07001
9406 Chips (GP) C16 D03 G07001
9407 Cracks C16 D03 G07001
Component Defects
9266 Component/Accessory Missing C16 D03 G07002 C16 Manufacturing Process Problem Identified
9270 Flash/Jagged Bottle Tip C16 D03 G04129 D03 Cause Traced to Manufacturing
9283 Orifice Out of Specification C16 D03 G04129 G04129 Tip
9296 Component Damaged C16 D03 G07002 G07002 Appropriate Code Not Available
9297 Component Loose C16 D03 G07002
9298 Disc Coating Poor C16 D03 G07002
9299 Component Deformed C16 D03 G07002

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 4 of 7
Component) for Vision Care

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
Foreign Material – Level 1 Complaints
9300 Foreign Material in Container C160503 D03 G07001 C160503 Packaging Contains Unintended Material
9301 Foreign Material on Lens C160503 D03 G07001 D03 Cause Traced to Manufacturing
9302 Foreign Material Embedded in Blister C160503 D03 G07002 G04014 Bottle
9311 Foreign Material Embedded in Container C160503 D03 G04014 G07002 Appropriate Code Not Available
9312 Foreign Material in Carton C160503 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9313 Foreign Material on Package C160503 D03 G07001
Labeling – Level 1 Complaints
9500 Label Missing Data C0502 D09 G04080 C05 Labeling and Instructions for Use/Maintenance
9501 Labeling Defect C05 D09 G04080 C0502 Incorrect Labeling and/or Instructions for Use
9502 No Label on Container C0502 D03 G04080 D03 Cause Traced to Manufacturing
9503 Smeared or Illegible Print C05 D09 G04080 D09 Cause Traced to Labeling
9504 No Over-label on Container C0502 D09 G04080 G04080 Label
Contact Lens Dimensions
9601 Axis Out of Spec C0707 D03 G07001 C0707 Incorrect Dimension
9602 Base Curve Out of Spec C0707 D03 G07001 D03 Cause Traced to Manufacturing
9603 Center Thickness Out of Spec C0707 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9604 Cylinder Out of Spec C0707 D03 G07001
9605 Diameter Out of Spec C0707 D03 G07001
9606 Sagittal Depth Out of Spec C0707 D03 G07001
9607 Sphere Power Out of Spec C0707 D03 G07001
9608 Prism Out of Spec C0707 D03 G07001
9631 Axis Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9632 Base Curve Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9633 C.T. Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9634 Cylinder Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9635 Diameter Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9636 Sag. Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9637 Power Out of Spec ≥ 2X the Tolerance C0707 D03 G07001
9638 Prism Out of Spec ≥ 2X the Tolerance C0707 D03 G07001

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 5 of 7
Component) for Vision Care

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
Lens Care Stability
9610 Clarity Out of Limits C16 D03 G07001 C16 Manufacturing Process Problem Identified
9611 Color Out of Limits C16 D03 G07001 C23 Usage Problem Identified
9612 Odor Unusual C16 D03 G07001 D03 Cause Traced to Manufacturing
9613 pH Out of Limits C16 D03 G07001 D11 Cause Traced to User
9614 Preservative Out of Limits C16 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9615 Product Suspected Altered/Replaced C23 D11 G07001
9617 Tablet Not Intact C16 D03 G07001
9618 Tonicity/Osmolality Out of Limits C16 D03 G07001
9619 EDTA Out of Limits C16 D03 G07001
9620 Iron out of Specification C16 D03 G07001
9621 Biocidal Failed C16 D03 G07001
9622 Bioburden Failed C16 D03 G07001
9623 ID Test Failed C16 D03 G07001
9624 Appearance Out of Limits C16 D03 G07001
9627 Neutralization Failed C16 D03 G07001
9628 Active Out of Limits C16 D03 G07001
Package Quality Defects
9709 Tamper Evident Not Intact C1605 D03 G04094 C1605 Packaging Problem Identified
9700 Blister Seal Voids, Leakers C160501 D03 G07001 C160501 Packaging Compromised
9701 Container Cracked/Broken C1605 D03 G07001 D03 Cause Traced to Manufacturing
9702 Lens Caught in Seal C1605 D03 G07001 G04014 Bottle
9703 Carton Damage C1605 D03 G04094 G04020 Cap
9704 Carton Not Completely Sealed C1605 D03 G04094 G04080 Label
9705 No/Low Solution in Container C1605 D03 G07001 G04094 Packaging
9708 Stuck to Container C1605 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9710 Lidstock Damage C1605 D03 G04094
9713 Tamper Evident Comes Off Intact C1605 D03 G04094
9714 Cap Not Attached Properly C1605 D03 G04020
9715 Cap Melted C1605 D03 G04020
9716 Container Dented / Deformed C1605 D03 G04014

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 6 of 7
Component) for Vision Care

Code Evaluation Code Description Annex C Annex D Annex G IMDRF Code Description
9717 Container Discolored C1605 D03 G07001
9718 Carton Discolored C1605 D03 G04094
9719 Labeling Discolored C1605 D03 G04080
9720 No/Low Solution in Sealed Container C1605 D03 G07001
9721 Label Off Center C1605 D03 G04080
9722 Leaflet/Insert Defect C1605 D03 G07001
Product Integrity
9801 Incorrect Lens in Container C160504 D03 G07001 C16 Manufacturing Process Problem Identified
9802 Carton Label Different Than Contents C160504 D03 G07001 C160504 Packaging Contains Incorrect Device
9815 Incorrect Material C160504 D03 G07001 C0707 Incorrect Dimension
9825 Missing Disc or Lens Case C16 D03 G07001 D03 Cause Traced to Manufacturing
9803 Multiple Lenses in Container C16 D03 G07001 G04014 Bottle
9804 No Lens in Container C16 D03 G07001 G07001 Part/Component/Sub-assembly Term not Applicable
9808 Container Punctured C16 D03 G04014
9809 Leaks C16 D03 G07001
9811 Carton Missing Product C16 D03 G07001
9816 Leaks at Overcap C16 D03 G04014
9817 Leaks at Bottle Neck C16 D03 G04014
9818 Overcap Inner Diameter Out of Spec C0707 D03 G04014
9819 Spout Outer Diameter Out of Spec C0707 D03 G04014
9820 Bottle Neck Inner Diameter Out of Spec C0707 D03 G04014
9821 Wiper Seal Outer Diameter Out of Spec C0707 D03 G04014
9822 Spout Inner Diameter Out of Spec C0707 D03 G04014
9823 Pintle Outer Diameter Out Of Spec C0707 D03 G04014
9824 Deformity in Sealing Area C16 D03 G04014

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH HEALTH 12.1.1-GREF-2

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 7 of 7
Component) for Vision Care

Revisions

Rev: 3 Author: Tes Proud CR-000290448

Description of Changes:  Update IMDRF website link

Implementation Instructions: Upon Document Approval

Rev: 2 Author: Tes Proud CR-000265639

Description of Changes:  Add evaluation code 9722

Implementation Instructions: Upon Document Approval

Rev: 1 Author: Tes Proud CR-000258380

Description of Changes: New document

Implementation Instructions: Upon Document Approval

Viewed/Printed: 6 December 2022 7:35:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.1-GREF-2 Status: Effective Effective Date: 06/May/2022

CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :REF-000258683

Document Title :IMDRF Codes Annexes B, C, D and G (Cause Investigation, Component)

for Vision Care

Document ID :12.1.1-GREF-2

Signed By Date (GMT) Justification

Proud Tes 03/May/2022 Author Confirmation

15:10:59

Graham Meredith 03/May/2022 Functional Approval

21:41:38

Garrett Tricia M 06/May/2022 Quality Approval

12:20:00

Viewed/Printed: 6 December 2022 7:35:49 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258683 Rev 3