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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 85
2021 51 51
2022 62 69
2023 84 92
2024 78 80
2025 38 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 171 175
Device Emits Odor 28 36
Device Markings/Labelling Problem 22 22
Improper or Incorrect Procedure or Method 20 20
Contamination 18 19
Product Quality Problem 18 25
Labelling, Instructions for Use or Training Problem 13 13
Patient-Device Incompatibility 11 11
Insufficient Information 11 11
Patient Device Interaction Problem 8 8
Use of Device Problem 8 8
Appropriate Term/Code Not Available 8 9
Device Handling Problem 7 7
Contamination /Decontamination Problem 5 5
Contamination of Device Ingredient or Reagent 4 4
Improper Chemical Reaction 4 4
Output Problem 3 3
Defective Device 3 6
Material Integrity Problem 3 3
Nonstandard Device 3 3
Fluid/Blood Leak 3 3
Chemical Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Expiration Date Error 2 2
Component Missing 2 2
Device Damaged by Another Device 2 2
Failure to Disinfect 2 2
Break 1 1
Material Opacification 1 1
Peeled/Delaminated 1 2
Microbial Contamination of Device 1 1
Packaging Problem 1 1
Fungus in Device Environment 1 1
Difficult to Open or Close 1 1
Biocompatibility 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Eye Pain 75 84
Red Eye(s) 66 73
Blurred Vision 61 71
Eye Burn 58 58
Corneal Ulcer 55 55
Burning Sensation 53 61
Discomfort 44 45
Excessive Tear Production 32 34
No Clinical Signs, Symptoms or Conditions 32 33
Keratitis 32 32
Eye Infections 30 30
Corneal Abrasion 27 27
Pain 23 25
Dry Eye(s) 23 27
Conjunctivitis 22 23
Hyperemia 20 21
Inflammation 18 18
Foreign Body Sensation in Eye 16 16
No Known Impact Or Consequence To Patient 16 16
Corneal Edema 16 16
Corneal Scar 16 16
Swelling/ Edema 15 17
Eye Injury 13 14
Loss of Vision 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 15
Irritation 12 12
Visual Impairment 12 12
Corneal Infiltrates 10 10
Headache 9 12
Itching Sensation 9 10
Caustic/Chemical Burns 9 9
Visual Disturbances 9 9
Insufficient Information 9 10
Unspecified Infection 9 9
Corneal Clouding/Hazing 9 9
Acanthameba Keratitis 8 8
Purulent Discharge 8 8
Erythema 8 8
Erosion 7 7
Unspecified Eye / Vision Problem 7 8
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
Nausea 3 3
Skin Disorders 3 4
Iritis 3 3
Ptosis 3 3

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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