>

CONTROLLED DOCUMENT 12.1.19-GREF-4 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-4

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 1 of
Component) for Pharma Medical Device

Purpose
This document provides applicable IMDRF Codes for Annexes B, C, D and G to assist the user in selecting the appropriate codes for
Pharma Medical Device complaints. Refer to Documents (imdrf.org) for additional IMDRF codes.

Type of Sample Annex B Code and Description

Complaint B01 Testing of Actual Suspected Device
Retains B02 Testing of Device from Same Lot/Batch Retained by Manufacturer

Scenario Description Annex B Annex C Annex D Annex G IMDRF Code Description

Choice 1 = B13
Device was not returned, and plant
Choice 2 = B17 C20 D15 G00701*
evaluation was not completed.
Choice 3 = B12 B01 Testing of Actual/Suspected Device
Choice 1 = B13 B12 Trend Analysis
Device was discarded and plant
Choice 2 = B18 C20 D15 G00701* B13 Communications/Interviews
evaluation was not completed.
Choice 3 = B12 B14 Analysis of Production Records
Choice 1 = B14 B17 Device Not Returned
Device was not returned, and plant Choice 2 = B13 B18 Device Discarded
C20 D15 G00701* C19 No Device Problem Found
evaluation was completed. Choice 3 = B17 or B18
Choice 4 = B12 C20 No Findings Available
Choice 1 = B01 C23 Usage Problem Identified
Device was evaluated and no problem
Choice 2 = B13 C19 D14 G00701*
was found.
Choice 3 = B12

*Use G00701 if there is no specific component involved. If a specific component was involved, reference Documents (imdrf.org) to
select an appropriate code.

Viewed/Printed: 6 December 2022 7:39:56 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000338679 < > Rev 1 >
 >
CONTROLLED DOCUMENT 12.1.19-GREF-4 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-4

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes B, C, D and G (Cause Investigation, Page 2 of
Component) for Pharma Medical Device

Revisions

Rev: 1 Author: Sarum Sreng CR-000290448

Description of Changes: ▪ New document

Implementation Instructions: Upon Document Approval

Viewed/Printed: 6 December 2022 7:39:56 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000338679 < > Rev 1 >
 >
CONTROLLED DOCUMENT 12.1.19-GREF-4 Status: Effective Effective Date: 06/May/2022

CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :REF-000338679

Document Title :IMDRF Codes Annexes B C D and G (Cause Investigation Component) for
Pharma Medical Device

Document ID :12.1.19-GREF-4

Signed By Date (GMT) Justification

Proud Tes 03/May/2022 Author Confirmation

15:10:58

Graham Meredith 03/May/2022 Functional Approval

21:41:38

Garrett Tricia M 06/May/2022 Quality Approval

12:19:59

Viewed/Printed: 6 December 2022 7:39:57 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000338679 Rev 1