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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
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC
  SUBSTANTIALLY EQUIVALENT 1
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
2019 60 60
2020 82 82
2021 50 50
2022 62 62
2023 85 85
2024 62 64

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 174 175
Device Markings/Labelling Problem 28 28
Device Emits Odor 28 28
Contamination 26 26
Product Quality Problem 23 23
Improper or Incorrect Procedure or Method 21 21
Patient-Device Incompatibility 14 14
Labelling, Instructions for Use or Training Problem 13 13
Insufficient Information 11 11
Use of Device Problem 7 7
Device Handling Problem 7 7
Patient Device Interaction Problem 5 5
Contamination /Decontamination Problem 5 5
Appropriate Term/Code Not Available 5 5
Contamination of Device Ingredient or Reagent 4 4
Defective Device 3 3
Material Integrity Problem 3 3
Improper Chemical Reaction 3 3
Fluid/Blood Leak 3 3
Output Problem 3 3
Fungus in Device Environment 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Chemical Problem 2 2
Component Missing 2 2
Nonstandard Device 2 2
Defective Component 1 1
Expiration Date Error 1 1
Difficult to Open or Close 1 1
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Peeled/Delaminated 1 1
Microbial Contamination of Device 1 1
Difficult to Remove 1 1
Device Damaged by Another Device 1 1
Packaging Problem 1 1
Failure to Disinfect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 81 81
Red Eye(s) 69 69
Eye Pain 57 58
Corneal Ulcer 49 49
Eye Burn 44 44
Blurred Vision 42 42
Discomfort 40 41
Pain 39 39
Excessive Tear Production 30 30
No Clinical Signs, Symptoms or Conditions 30 30
Keratitis 28 28
Eye Infections 27 27
No Known Impact Or Consequence To Patient 24 24
Irritation 23 23
Corneal Abrasion 22 22
Dry Eye(s) 21 21
Conjunctivitis 19 20
Hyperemia 19 20
Inflammation 17 17
Foreign Body Sensation in Eye 16 16
Corneal Scar 16 16
Eye Injury 15 15
Loss of Vision 14 14
Corneal Edema 13 13
Erythema 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Swelling/ Edema 12 12
Caustic/Chemical Burns 11 11
Unspecified Infection 10 10
Corneal Infiltrates 10 10
Visual Impairment 9 9
Headache 9 9
Itching Sensation 9 9
Corneal Clouding/Hazing 9 9
Visual Disturbances 8 8
Insufficient Information 8 8
Purulent Discharge 7 7
Unspecified Eye / Vision Problem 7 7
Acanthameba Keratitis 6 6
No Code Available 6 6
Hypersensitivity/Allergic reaction 6 6
Swelling 6 6
Fungal Infection 5 5
Discharge 4 4
Skin Inflammation/ Irritation 4 4
Distress 4 4
Overwear Syndrome 3 3
Fluid Discharge 3 3
Reaction 3 3
Skin Irritation 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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