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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 17 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 132 137
Device Emits Odor 28 36
Improper or Incorrect Procedure or Method 19 19
Product Quality Problem 19 26
Device Markings/Labelling Problem 18 18
Patient-Device Incompatibility 13 13
Use of Device Problem 10 10
Labelling, Instructions for Use or Training Problem 10 10
Patient Device Interaction Problem 9 9
Insufficient Information 8 8
Appropriate Term/Code Not Available 8 9
Device Handling Problem 7 7
Improper Chemical Reaction 5 5
Contamination /Decontamination Problem 5 5
Fluid/Blood Leak 4 4
Material Integrity Problem 4 4
Contamination of Device Ingredient or Reagent 4 4
Output Problem 3 3
Defective Device 3 6
Nonstandard Device 3 3
Contamination 3 4
Chemical Problem 2 2
Failure to Disinfect 2 2
Expiration Date Error 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Damaged by Another Device 2 2
Packaging Problem 2 2
Biocompatibility 1 1
Difficult to Open or Close 1 1
Fungus in Device Environment 1 1
Gas/Air Leak 1 1
Component Missing 1 1
Fail-Safe Problem 1 1
Microbial Contamination of Device 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Peeled/Delaminated 1 2
Material Opacification 1 1
Break 1 1
Pressure Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Ingredient or Reagent Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Eye Pain 79 89
Blurred Vision 64 73
Eye Burn 61 61
Red Eye(s) 54 60
Corneal Ulcer 44 44
Discomfort 38 39
No Clinical Signs, Symptoms or Conditions 36 37
Burning Sensation 33 41
Excessive Tear Production 30 31
Eye Infections 30 30
Corneal Abrasion 29 29
Hyperemia 23 27
Keratitis 21 21
Conjunctivitis 20 21
Dry Eye(s) 19 23
Foreign Body Sensation in Eye 14 15
Swelling/ Edema 14 15
Corneal Scar 13 13
Eye Injury 13 13
Inflammation 13 13
Corneal Edema 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Visual Impairment 11 11
Loss of Vision 11 11
Insufficient Information 10 11
Caustic/Chemical Burns 10 10
Visual Disturbances 9 9
Corneal Infiltrates 9 9
Corneal Clouding/Hazing 9 9
Purulent Discharge 7 7
Erosion 7 7
Unspecified Eye / Vision Problem 7 8
Hypersensitivity/Allergic reaction 7 7
Acanthameba Keratitis 6 6
Headache 6 9
Itching Sensation 5 5
Pain 5 5
Fungal Infection 4 4
Distress 4 4
Unspecified Infection 4 4
Erythema 3 3
Iritis 3 3
Ptosis 3 3
Skin Disorders 3 4
Skin Inflammation/ Irritation 3 3
Overwear Syndrome 3 3
Skin Discoloration 2 2
Nausea 2 2
Chemical Exposure 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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