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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, soft lens products
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
CHEMTEX USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTE NORTH AMERICA, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 51 51
2022 62 69
2023 84 92
2024 78 80
2025 45 47
2026 49 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 130 135
Improper or Incorrect Procedure or Method 23 23
Appropriate Device Problem Term/Code Not Available 12 13
Labelling, Instructions for Use or Training Problem 10 10
Device Handling Problem 7 7
Device Markings/Labelling Problem 7 7
Insufficient Device Problem Information 7 7
Contamination /Decontamination Problem 6 6
Improper Chemical Reaction 6 6
Product Quality Problem 5 5
Use of Device Problem 5 5
Device Emits Odor 4 4
Therapeutic or Diagnostic Output Failure 4 4
Nonstandard Device 3 3
Material Integrity Problem 3 3
Fluid/Blood Leak 3 3
Chemical Problem 3 3
Device Damaged by Another Device 2 2
Expiration Date Error 2 2
Packaging Problem 2 2
Patient-Device Incompatibility 2 2
Failure to Disinfect 2 2
Component Missing 1 1
Microbial Contamination of Device 1 1
Contamination 1 1
Contamination of Device Ingredient or Reagent 1 1
Patient Device Interaction Problem 1 1
Material Opacification 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Eye Pain 87 97
Blurred Vision 72 81
Eye Burn 70 70
Eye Irritation 70 71
Red Eye(s) 58 64
Corneal Ulcer 49 49
Discomfort 39 40
No Clinical Signs, Symptoms or Conditions 39 40
Burning Sensation 37 45
Eye Infections 33 33
Excessive Tear Production 33 34
Corneal Abrasion 32 32
Keratitis 24 24
Hyperemia 24 28
Conjunctivitis 21 22
Dry Eye(s) 19 23
Inflammation 16 16
Photophobia 16 16
Foreign Body Sensation in Eye 16 17
Corneal Scar 15 15
Visual Impairment 14 14
Swelling/ Edema 14 15
Corneal Edema 14 14
Eye Injury 13 13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 12 12
Loss of Vision 12 12
Caustic/Chemical Burns 11 11
Insufficient Information 10 11
Corneal Clouding/Hazing 9 9
Visual Disturbances 9 9
Corneal Infiltrates 9 9
Hypersensitivity/Allergic reaction 8 8
Pain 8 8
Erosion 8 8
Purulent Discharge 8 8
Unspecified Eye / Vision Problem 7 8
Headache 7 10
Infective Keratitis 6 6
Itching Sensation 5 5
Ptosis 4 4
Fungal Infection 4 4
Unspecified Infection 4 4
Distress 4 4
Overwear Syndrome 3 3
Fluid Discharge 3 3
Erythema 3 3
Skin Disorders 3 4
Iritis 3 3
Skin Inflammation/ Irritation 3 3
Skin Discoloration 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC II Feb-03-2021
2 Family Dollar Stores, Llc. II Aug-17-2022
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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