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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
CHEMTEX USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OTE NORTH AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
THE LIFESTYLE COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 82 82
2021 50 50
2022 62 62
2023 85 85
2024 78 80
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 162 163
Device Emits Odor 28 28
Device Markings/Labelling Problem 20 20
Product Quality Problem 19 19
Contamination 18 18
Improper or Incorrect Procedure or Method 16 16
Labelling, Instructions for Use or Training Problem 12 12
Patient-Device Incompatibility 10 10
Insufficient Information 10 10
Use of Device Problem 7 7
Device Handling Problem 7 7
Appropriate Term/Code Not Available 6 6
Contamination /Decontamination Problem 5 5
Patient Device Interaction Problem 5 5
Contamination of Device Ingredient or Reagent 4 4
Output Problem 3 3
Material Integrity Problem 3 3
Improper Chemical Reaction 3 3
Fluid/Blood Leak 3 3
Chemical Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Defective Device 2 2
Component Missing 2 2
Device Damaged by Another Device 2 2
Nonstandard Device 2 2
Fungus in Device Environment 2 2
Failure to Disinfect 2 2
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Peeled/Delaminated 1 1
Expiration Date Error 1 1
Microbial Contamination of Device 1 1
Packaging Problem 1 1
Difficult to Open or Close 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Eye Pain 66 67
Red Eye(s) 60 60
Blurred Vision 55 55
Eye Burn 53 53
Corneal Ulcer 51 51
Burning Sensation 50 50
Discomfort 40 41
Excessive Tear Production 31 31
No Clinical Signs, Symptoms or Conditions 31 31
Keratitis 31 31
Eye Infections 29 29
Corneal Abrasion 26 26
Pain 23 23
Conjunctivitis 22 23
Hyperemia 20 21
Dry Eye(s) 20 20
Inflammation 18 18
Foreign Body Sensation in Eye 16 16
No Known Impact Or Consequence To Patient 16 16
Corneal Scar 16 16
Corneal Edema 16 16
Eye Injury 13 13
Swelling/ Edema 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Loss of Vision 12 12
Irritation 12 12
Corneal Infiltrates 10 10
Visual Impairment 10 10
Headache 9 9
Caustic/Chemical Burns 9 9
Unspecified Infection 9 9
Corneal Clouding/Hazing 9 9
Purulent Discharge 8 8
Itching Sensation 8 8
Insufficient Information 8 8
Visual Disturbances 8 8
Erythema 8 8
Acanthameba Keratitis 7 7
Unspecified Eye / Vision Problem 7 7
Erosion 6 6
Hypersensitivity/Allergic reaction 6 6
No Code Available 5 5
Fungal Infection 5 5
Skin Inflammation/ Irritation 4 4
Distress 4 4
Overwear Syndrome 3 3
Ptosis 3 3
Hemorrhage/Bleeding 2 2
Vitreous Floaters 2 2
Fluid Discharge 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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