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CONTROLLED DOCUMENT 12.1.1-GREF-1 Status: Effective Effective Date: 07/Nov/2022
BAUSCH + LOMB 12.1.1-GREF-1

Global Reference Document Revision: 4
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 1 of 14
Effects) for Vision Care
Purpose
This document provides a list of contact lens and lens care complaint reasons and IMDRF Codes for Annexes A, E and F to assist
the user in selecting the appropriate codes for Vision Care product complaints. Refer to http://www.imdrf.org/working-
groups/adverse-eventterminology for additional IMDRF codes.
Note: For reportable events, evaluate Annex E and F codes for appropriate selection.
I. Contact Lens
Contact Lens Annex A Annex E Annex F
Annex E IMDRF Code Description
Complaint Reason IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
A24 Adverse Event Without E082901 Infective F12 Serious Injury/ Illness/ Keratitis due to infection, including infection by
Acanthamoeba Keratitis
Identified Device or Use Problem Keratitis Impairment Acanthamoeba.
A24 Adverse Event Without F11 Minor Injury/ Illness/
Allergic Conjunctivitis E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
Identified Device or Use Problem Impairment
E0402 A local or general reaction of an organism following contact
Allergic Reaction Hypersensitivity/Allergic with a specific allergen to which it has been previously
reaction exposed and to which it has become sensitized.
A24 Adverse Event Without E2402 Appropriate Term F11 Minor Injury/ Illness/ The clinical signs, symptoms and conditions are not
Allergy Symptoms
Identified Device or Use Problem / Code Not Available Impairment adequately described by any other term.
E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Base Curve A0201 Product Quality Problem
Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A24 Adverse Event Without F11 Minor Injury/ Illness/ A localized physical condition in which part of the body
Blepharitis E2326 Inflammation
Identified Device or Use Problem Impairment becomes reddened, swollen, or hot and often painful.
A020503 Unsealed Device E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Blister Seal Void
Packaging Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Breakage (GP) A25 No Apparent Adverse Event
Bubbles A0201 Product Quality Problem
A24 Adverse Event Without F26 No Health A sensation of stinging or heat, not necessarily
Burning/Stinging E1705 Burning Sensation
Identified Device or Use Problem Consequences or Impact accompanied by redness or physical signs of irritation.
Carton Label Different E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A0201 Product Quality Problem
Than Contents Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Viewed/Printed: 6 December 2022 7:33:17 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258680 < > Rev 4 >
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Carton Missing Product A0201 Product Quality Problem
A24 Adverse Event Without F12 Serious Injury/ Illness/ Inflammation of the dermis and subcutaneous tissues
Cellulitis E172002 Cellulitis
Identified Device or Use Problem Impairment caused by a bacterial infection.
Center Thickness A0201 Product Quality Problem
Chemical Burns/Reaction E081902 Eye Burn Burn injury, including chemical burn, to any part of the eye.
Cloudy A0409 Material Opacification
A24 Adverse Event Without E2402 Appropriate Term F26 No Health The clinical signs, symptoms and conditions are not
Conjunctival Impression
Identified Device or Use Problem / Code Not Available Consequences or Impact adequately described by any other term.
Conjunctivitis E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
A24 Adverse Event Without E081901 Corneal F11 Minor Injury/ Illness/
Corneal Abrasion Injury to the epithelium of the cornea.
Identified Device or Use Problem Abrasion Impairment
A24 Adverse Event Without F11 Minor Injury/ Illness/ An inflammatory process characterized by the
Corneal Abscess E172001 Abscess
Identified Device or Use Problem Impairment accumulation of pus within a newly formed tissue cavity.
Corneal Edema E0807 Corneal Edema Hazy, swollen cornea.
An eating away or breakdown of any type of external or
internal human tissue including but not limited to skin,
teeth, mucosa, or somatic, which involves only the outer
Corneal Erosion E2006 Erosion tissue layer. When tissue surrounds an implanted device,
the tissue breakdown may result in migration and loss of
the implant material and may result in further
complications such as infection or abscess.
Corneal Event E0819 Eye Injury Damage to the eye.
Discrete, small lesions present in the cornea as a result of
Corneal Infiltrates E0809 Corneal Infiltrates corneal inflammation and, in some cases, after soft contact
lens wear especially extended-wear lenses.
A24 Adverse Event Without E0805 Corneal F11 Minor Injury/ Illness/ Clouding of the middle area of the cornea, usually as a
Corneal Opacity
Identified Device or Use Problem Clouding/Hazing Impairment result of scarring due to infection, injury, or inflammation.
>


A24 Adverse Event Without E0812 Corneal Scar F11 Minor Injury/ Illness/ Replacement of corneal tissue with scar tissue as a result of
Corneal Scar
Identified Device or Use Problem Impairment injury to the deeper layers of the cornea.
Corneal Staining
Area of epithelial tissue loss from corneal surface;
Corneal Ulcer E0814 Corneal Ulcer associated with inflammatory cells in the cornea and
anterior chamber.
Corneal Warpage
Damage A25 No Apparent Adverse Event
Defective A0201 Product Quality Problem
An inflammatory process affecting the skin. Signs include
A24 Adverse Event Without E1720 Skin F11 Minor Injury/ Illness/ red rash, itching, and blister formation. Representative
Dermatitis
Identified Device or Use Problem Inflammation/ Irritation Impairment examples are contact dermatitis, atopic dermatitis, and
seborrheic dermatitis.
Diameter A0201 Product Quality Problem
Dirty A25 No Apparent Adverse Event
Discolored Lens A25 No Apparent Adverse Event
Discomfort
A syndrome characterized by dryness of the cornea and
A24 Adverse Event Without F26 No Health conjunctiva. It is usually caused by a deficiency in tear
Dry Eyes E0815 Dry Eye(s)
Identified Device or Use Problem Consequences or Impact production. Symptoms include a feeling of burning eyes and
a possible foreign body presence in the eye.
Edge A0201 Product Quality Problem
Epithelial Defect
Excess Material/Piece of E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Material Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
>


Film/Deposits A25 No Apparent Adverse Event
Folded A0201 Product Quality Problem
Foreign Material in Carton A1801 Contamination
Foreign Material in E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A1801 Contamination
Container Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Foreign Material on Lens A1801 Contamination
Foreign Material on E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A1801 Contamination
Package Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A24 Adverse Event Without F12 Serious Injury/ Illness/
Fusarium Keratitis E1902 Fungal Infection An infection caused by a fungus.
Giant Papillary A24 Adverse Event Without F11 Minor Injury/ Illness/
E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
Conjunctivitis (GPC) Identified Device or Use Problem Impairment
Hazy ring around bright lights seen by some patients with
Halos E0823 Halo refractive error or optical defects, e.g. cataracts, or corneal
swelling.
A24 Adverse Event Without F26 No Health Pain in various parts of the head, not confined to the area
Headache E0116 Headache
Identified Device or Use Problem Consequences or Impact of distribution of any nerve.
Herpes Simplex Keratitis E1907 Viral Infection Any disease caused by a virus.
Hole A25 No Apparent Adverse Event
Hypopyon E0825 Hypopyon An accumulation of pus in the anterior chamber of the eye.
Incorrect Product in E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Infection E0818 Eye Infections An infection of any part of the eye, including the eyelid.
Infiltrative Keratitis E0829 Keratitis Inflammation of the cornea.
Inflammation E2326 Inflammation
>


Injection
Iritis E0828 Iritis Inflammation of the iris.
A24 Adverse Event Without F26 No Health A generic term used to describe sensations that bother the
Irritation E0845 Eye Irritation
Identified Device or Use Problem Consequences or Impact eyes like dryness, itchiness, burning and grittiness.
Keratitis E0829 Keratitis Inflammation of the cornea.
Keratoconjunctivitis E2326 Inflammation
Label Missing Data A210105 Missing Information
Label Smeared or Illegible E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A210102 Illegible Information
Print Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A2101 Device Markings/Labelling E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Labeling Defect
Problem Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Lens Stuck to Container A0201 Product Quality Problem
A24 Adverse Event Without F11 Minor Injury/ Illness/ Increased sensitivity of the eyes to light causing discomfort
Light Sensitivity E083804 Photophobia
Identified Device or Use Problem Impairment or pain.
Medical Complaint
A24 Adverse Event Without F12 Serious Injury/ Illness/ An infection of any part of the eye, including the eyelid.
Microbial Keratitis E0818 Eye Infections
Identified Device or Use Problem Impairment Inflammation of the cornea.
Multiple Lenses in E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A24 Adverse Event Without E0510 F11 Minor Injury/ Illness/
Neovascularization The formation of new blood vessels.
Identified Device or Use Problem Neovascularization Impairment
Nicks/Chips A25 No Apparent Adverse Event
No/Low Saline in E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
No Lens in Container A0201 Product Quality Problem
>


Off Power A0201 Product Quality Problem
Out of Round A0201 Product Quality Problem
Package Defect A0205 Packaging Problem
Poor Fit A0201 Product Quality Problem
Poor Handling A25 No Apparent Adverse Event
A24 Adverse Event Without F26 No Health
Poor Visual Acuity/Optics E083901 Blurred Vision The loss of visual acuity (sharpness of vision).
Identified Device or Use Problem Consequences or Impact
Poor Wettability A0201 Product Quality Problem
Print Pattern Irregular A0201 Product Quality Problem
Print Pattern Missing A0201 Product Quality Problem
Print Pattern Off Center A0201 Product Quality Problem
Print Pattern Off Color A0201 Product Quality Problem
Received Damaged A0201 Product Quality Problem
A24 Adverse Event Without F26 No Health Lay term applied to any condition with dilation of
Red Eye E0833 Red Eye(s)
Identified Device or Use Problem Consequences or Impact conjunctival or ciliary blood vessels; innumerable causes.
Rolled Edge A0201 Product Quality Problem
Scratched Eye E0819 Eye Injury Damage to the eye.
Scratches A25 No Apparent Adverse Event
Spots A25 No Apparent Adverse Event
>


Stye
Subconjunctival A24 Adverse Event Without E0850 Conjunctival F11 Minor Injury/ Illness/
Blood extravasation in the conjunctiva.
Hemorrhage Identified Device or Use Problem Hemorrhage Impairment
Superficial Punctate A24 Adverse Event Without F11 Minor Injury/ Illness/
E0829 Keratitis Inflammation of the cornea.
Keratitis (SPK) Identified Device or Use Problem Impairment
Surface Quality A0201 Product Quality Problem
Tamper Evident Not Intact
Tint Loss A25 No Apparent Adverse Event
Tint Off Color A0201 Product Quality Problem
Tore In Eye A0201 Product Quality Problem
Torn A25 No Apparent Adverse Event
Uveitis E0837 Uveitis Inflammation of the uvea.
II. Lens Care

Lens Care Annex E IMDRF Code Annex F IMDRF Code and
Annex A IMDRF Code and Term Annex E IMDRF Description
Complaint Reason and Term Term
A24 Adverse Event Without E082901 Infective F12 Serious Injury/ Illness/
Acanthamoeba Keratitis Keratitis due to infection, including by Acanthamoeba.
Identified Device or Use Problem Keratitis Impairment
A24 Adverse Event Without F11 Minor Injury/ Illness /
Allergic Conjunctivitis E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
E0402 A local or general reaction of an organism following contact
Allergic Reaction Hypersensitivity/Allergic with a specific allergen to which it has been previously
reaction exposed and to which it has become sensitized.
A24 Adverse Event Without E2402 Appropriate Term F11 Minor Injury/ Illness / The clinical signs, symptoms and conditions are not
Allergy Symptoms
>


A24 Adverse Event Without F11 Minor Injury/ Illness / A localized physical condition in which part of the body
Blepharitis E2326 Inflammation
Bottle/Container Tip A0201 Product Quality Problem
A24 Adverse Event Without F26 No Health A sensation of stinging or heat, not necessarily
Burning/Stinging E1705 Burning Sensation
Identified Device or Use Problem Consequences or Impact accompanied by redness or physical signs of irritation.
Carton Label Different E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Than Contents Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Carton Missing Product A0201 Product Quality Problem
A24 Adverse Event Without F12 Serious Injury/ Illness/ Inflammation of the dermis and subcutaneous tissues
Cellulitis E172002 Cellulitis
Identified Device or Use Problem Impairment caused by a bacterial infection.
A24 Adverse Event Without F11 Minor Injury/ Illness / Burn injury, including chemical burn, to any part of the eye.
Chemical Burns/Reaction E081902 Eye Burn
Identified Device or Use Problem Impairment A burn caused by exposure to chemical substances.
Chemical Keratitis E0829 Keratitis Inflammation of the cornea.
Clogged/Residue of E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A25 No Apparent Adverse Event
Product Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A030203 Precipitate in Device or E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Cloudy
Device Ingredient Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Component/Accessory E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A0202 Defective Component
Damaged Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Component/Accessory E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Missing Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Conjunctivitis E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
Container Empty/Partial A140304 Volume Accuracy E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Fill Problem Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A24 Adverse Event Without E081901 Corneal F11 Minor Injury/ Illness /
Corneal Abrasion Injury to the epithelium of the cornea.
Identified Device or Use Problem Abrasion Impairment
A24 Adverse Event Without F11 Minor Injury/ Illness / An inflammatory process characterized by the
Corneal Abscess E172001 Abscess
Identified Device or Use Problem Impairment accumulation of pus within a newly formed tissue cavity.
Corneal Burns E081902 Eye Burn Burn injury, including chemical burn, to any part of the eye.
>


Corneal Edema E0807 Corneal Edema Hazy, swollen cornea.
An eating away or breakdown of any type of external or
internal human tissue including but not limited to skin,
teeth, mucosa, or somatic, which involves only the outer
Corneal Erosion E2006 Erosion tissue layer. When tissue surrounds an implanted device,
the tissue breakdown may result in migration and loss of
the implant material and may result in further
complications such as infection or abscess.
Corneal Event E0819 Eye Injury Damage to the eye.
Discrete, small lesions present in the cornea as a result of
Corneal Infiltrates E0809 Corneal Infiltrates corneal inflammation and, in some cases, after soft contact
lens wear especially extended-wear lenses.
A24 Adverse Event Without E0805 Corneal F11 Minor Injury/ Illness / Clouding of the middle area of the cornea, usually as a
Corneal Opacity
Identified Device or Use Problem Clouding/Hazing Impairment result of scarring due to infection, injury, or inflammation.
A24 Adverse Event Without E0812 Corneal Scar F11 Minor Injury/ Illness / Replacement of corneal tissue with scar tissue as a result of
Corneal Scar
Identified Device or Use Problem Impairment injury to the deeper layers of the cornea.
Corneal Staining
Area of epithelial tissue loss from corneal surface;
Corneal Ulcer E0814 Corneal Ulcer associated with inflammatory cells in the cornea and
anterior chamber.
Corneal Warpage
Defective A0201 Product Quality Problem
An inflammatory process affecting the skin. Signs include
A24 Adverse Event Without E1720 Skin F11 Minor Injury/ Illness / red rash, itching, and blister formation. Representative
Dermatitis
Identified Device or Use Problem Inflammation/ Irritation Impairment examples are contact dermatitis, atopic dermatitis, and
seborrheic dermatitis.
A051104 Difficult to Open or E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Difficult To Open/Close
Close Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Difficult To Remove A020501 Difficult to Open or E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Tamper Evident Remove Packaging Material Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
>

Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 10 of
Effects) for Vision Care 14

Disc Coating Poor A040505 Flaked
Discolored – 1st Use – E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A030208 Unexpected Color
Level 1 Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Discolored – Reuse – Level E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
2 Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Discomfort
Dispensing Performance A0201 Product Quality Problem
A24 Adverse Event Without F26 No Health A sensation of lightheadedness, unsteadiness, turning,
Dizziness E0112 Dizziness
Identified Device or Use Problem Consequences or Impact spinning or rocking.
A syndrome characterized by dryness of the cornea and
A24 Adverse Event Without F26 No Health conjunctiva. It is usually caused by a deficiency in tear
Dry Eyes E0815 Dry Eye(s)
Identified Device or Use Problem Consequences or Impact production. Symptoms include a feeling of burning eyes and
a possible foreign body presence in the eye.
EasySept Missing Disc or E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Lens Case Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
A24 Adverse Event Without F12 Serious Injury/ Illness/ Inflammation of the intraocular fluids or tissues usually
Endophthalmitis E0816 Endophthalmitis
Identified Device or Use Problem Impairment with microbial organisms.
Epithelial Defect
Foreign Material in Carton A1801 Contamination
Foreign Material in E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A1801 Contamination
Foreign Material on E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A1801 Contamination
Package Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Fusarium Keratitis E1902 Fungal Infection An infection caused by a fungus.
Giant Papillary A24 Adverse Event Without F11 Minor Injury/ Illness /
E0804 Conjunctivitis Inflammation of the conjunctiva of the eye.
Conjunctivitis (GPC) Identified Device or Use Problem Impairment
Hazy ring around bright lights seen by some patients with
Halos E0823 Halo refractive error or optical defects, e.g. cataracts, or corneal
swelling.
>


A24 Adverse Event Without F26 No Health Pain in various parts of the head, not confined to the area
Headache E0116 Headache
Identified Device or Use Problem Consequences or Impact of distribution of any nerve.
Herpes Simplex Keratitis E1907 Viral Infection Any disease caused by a virus.
Ineffective A0105 Lack of Effect
Infection E0818 Eye Infections An infection of any part of the eye, including the eyelid.
Infiltrative Keratitis E0829 Keratitis Inflammation of the cornea.
Inflammation E2326 Inflammation
A2303 Improper or Incorrect E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Ingestion
Procedure or Method Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Injection
Iritis E0828 Iritis Inflammation of the iris.
A24 Adverse Event Without F26 No Health A generic term used to describe sensations that bother the
Irritation E0845 Eye Irritation
Identified Device or Use Problem Consequences or Impact eyes like dryness, itchiness, burning and grittiness.
A24 Adverse Event Without F26 No Health
Itching E1708 Itching Sensation An irritating feeling that produces the desire to scratch.
Identified Device or Use Problem Consequences or Impact
Keratitis E0829 Keratitis Inflammation of the cornea.
Keratoconjunctivitis E2326 Inflammation
Label Missing Data A210105 Missing Information
A2101 Device Markings/Labelling E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Labeling Defect
Problem Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Leaks A0202 Defective Component
Lenses Damaged A25 No Apparent Adverse Event
>


Lenses Discolored A25 No Apparent Adverse Event
Lenses Filmy/Cloudy A25 No Apparent Adverse Event
A24 Adverse Event Without F11 Minor Injury/ Illness / Increased sensitivity of the eyes to light causing discomfort
Light Sensitivity E083804 Photophobia
Identified Device or Use Problem Impairment or pain.
Medical Complaint
Meibomianitis E2326 Inflammation
A24 Adverse Event Without F12 Serious Injury/ Illness/ An infection of any part of the eye, including the eyelid.
Microbial Keratitis E0818 Eye Infections
Identified Device or Use Problem Impairment Inflammation of the cornea.
Missing Disc or Lens Case A0201 Product Quality Problem
Missing Global Lens Case A0201 Product Quality Problem
Odor Unusual – 1st Use – E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A0301 Device Emits Odor
Odor Unusual – Reuse – E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
Package Defect A0205 Packaging Problem
A24 Adverse Event Without F26 No Health Lay term applied to any condition with dilation of
Red Eye E0833 Red Eye(s)
Identified Device or Use Problem Consequences or Impact conjunctival or ciliary blood vessels; innumerable causes.
Scratched Eye E0819 Eye Injury Damage to the eye.
Shipper Missing Product A25 No Apparent Adverse Event
Skin Reaction – Level 1 E171601 Erythema Red discoloration of the skin.
Skin Reaction – Transient A24 Adverse Event Without F26 No Health
E171601 Erythema Red discoloration of the skin.
Red Streaks – Level 2 Identified Device or Use Problem Consequences or Impact
Stye
>


Subconjunctival A24 Adverse Event Without E0850 Conjunctival F11 Minor Injury/ Illness/
Blood extravasation in the conjunctiva.
Hemorrhage Identified Device or Use Problem Hemorrhage Impairment
Superficial Punctate A24 Adverse Event Without F11 Minor Injury/ Illness /
E0829 Keratitis Inflammation of the cornea.
Keratitis (SPK) Identified Device or Use Problem Impairment
A24 Adverse Event Without F26 No Health Enlargement or expansion in size of a body part from injury
Swelling E2338 Swelling/ Edema
Identified Device or Use Problem Consequences or Impact or inflammation.
Tamper Evident Comes E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
A0205 Packaging Problem
Off Intact Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Tamper Evident Not Intact
Texture Unusual – 1st Use E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
– Level 1 Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Texture Unusual – Reuse E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
– Level 2 Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Uveitis E0837 Uveitis Inflammation of the uvea.
Viscosity – 1st Use – Level E2403 No Clinical Signs, F26 No Health No patient involvement or, no observable clinical symptoms
1 Symptoms or Conditions Consequences or Impact or a change in symptoms is identified in the patient.
Viscosity – Reuse – Level 2 A25 No Apparent Adverse Event
A24 Adverse Event Without F11 Minor Injury/ Illness / Decreased ability to see to a degree that requires corrective
Vision Loss, Temporary E0839 Visual Impairment
Identified Device or Use Problem Impairment measures
A24 Adverse Event Without E0838 Visual F26 No Health An interference to normal eyesight without necessarily
Visual Disturbances
Identified Device or Use Problem Disturbances Consequences or Impact affecting visual acuity.
>

Revisions
Rev: 4 Author: Tes Proud CR-000351507
Description of Changes: ▪ Contact Lens category:

Edit Breakage (GP) Annex A code per system mapping.
Add Tamper Evident Not Intact complaint reason.
Implementation Instructions: Upon Document Approval
Description of Changes: ▪ Update IMDRF website link.

▪ Code updates for newly published IMDRF codes and per system mapping.
Description of Changes: ▪ Correct Annex A code for Breakage (GP) per system mapping.
▪ Add complaint reason of Stye for both Contact Lens and Lens Care.
>
CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :REF-000258680
Document Title :IMDRF Codes Annexes A, E and F (Problem and Health Effects) for
Vision Care
Document ID :12.1.1-GREF-1
Signed By Date (GMT) Justification
Garrett Tricia M 07/Nov/2022 Quality Approval

12:51:35
Antypenko Lina 26/Oct/2022 Functional Approval

19:37:21
Proud Tes 26/Oct/2022 Author Confirmation

19:53:29
Graham Meredith 31/Oct/2022 Functional Approval

22:13:17
Viewed/Printed: 6 December 2022 7:33:17 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258680 Rev 4

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CONTROLLED DOCUMENT 12.1.1-GREF-1 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.1-GREF-1

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

BAUSCH + LOMB 12.1.1-GREF-1

Contact Lens Annex A Annex E Annex F

II. Lens Care

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Lens Care Annex E IMDRF Code Annex F IMDRF Code and

BAUSCH + LOMB 12.1.1-GREF-1

Rev: 4 Author: Tes Proud CR-000351507

Description of Changes: ▪ Contact Lens category:

Implementation Instructions: Upon Document Approval

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

Implementation Instructions: Upon Document Approval

Signed By Date (GMT) Justification

Garrett Tricia M 07/Nov/2022 Quality Approval

Antypenko Lina 26/Oct/2022 Functional Approval

Proud Tes 26/Oct/2022 Author Confirmation

Graham Meredith 31/Oct/2022 Functional Approval

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