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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 150 150
Device Markings/Labelling Problem 28 28
Device Emits Odor 27 27
Contamination 26 26
Product Quality Problem 23 23
Improper or Incorrect Procedure or Method 17 17
Patient-Device Incompatibility 14 14
Labelling, Instructions for Use or Training Problem 13 13
Insufficient Information 11 11
Use of Device Problem 6 6
Device Handling Problem 6 6
Appropriate Term/Code Not Available 5 5
Contamination /Decontamination Problem 5 5
Contamination of Device Ingredient or Reagent 4 4
Patient Device Interaction Problem 4 4
Output Problem 3 3
Defective Device 3 3
Material Integrity Problem 3 3
Fungus in Device Environment 3 3
Fluid/Blood Leak 3 3
Nonstandard Device 2 2
Component Missing 2 2
Chemical Problem 2 2
Improper Chemical Reaction 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Open or Close 1 1
Packaging Problem 1 1
Expiration Date Error 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Difficult to Remove 1 1
Peeled/Delaminated 1 1
Break 1 1
Failure to Disinfect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 78 78
Red Eye(s) 58 58
Eye Pain 46 46
Discomfort 39 39
Pain 39 39
Eye Burn 36 36
Blurred Vision 34 34
Corneal Ulcer 34 34
No Clinical Signs, Symptoms or Conditions 27 27
Eye Infections 26 26
Keratitis 25 25
Excessive Tear Production 25 25
No Known Impact Or Consequence To Patient 24 24
Irritation 23 23
Corneal Abrasion 22 22
Dry Eye(s) 18 18
Hyperemia 17 17
Inflammation 15 15
Eye Injury 15 15
Conjunctivitis 15 15
Foreign Body Sensation in Eye 13 13
Corneal Scar 13 13
Erythema 12 12
Loss of Vision 12 12
Swelling/ Edema 12 12
Corneal Edema 11 11
Unspecified Infection 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Headache 9 9
Itching Sensation 9 9
Caustic/Chemical Burns 9 9
Visual Disturbances 8 8
Corneal Infiltrates 8 8
Insufficient Information 8 8
Unspecified Eye / Vision Problem 6 6
Swelling 6 6
No Code Available 6 6
Hypersensitivity/Allergic reaction 6 6
Purulent Discharge 6 6
Corneal Clouding/Hazing 5 5
Acanthameba Keratitis 5 5
Fungal Infection 5 5
Skin Inflammation/ Irritation 4 4
Distress 4 4
Visual Impairment 4 4
Discharge 4 4
Skin Irritation 3 3
Overwear Syndrome 3 3
Reaction 3 3
Fluid Discharge 3 3
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 2 2
Chemical Exposure 2 2
Ptosis 2 2
Ulcer 2 2
Injury 2 2
Increased Sensitivity 2 2
Skin Discoloration 2 2
Nausea 2 2
Hypopyon 2 2
Hemorrhage/Bleeding 2 2
Iritis 2 2
Vitreous Floaters 2 2
Erosion 2 2
Increased Sensitivity 2 2
Localized Skin Lesion 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Nodule 1 1
Reaction to Medicinal Component of Device 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Burn(s) 1 1
Abdominal Pain 1 1
Endophthalmitis 1 1
Intraocular Infection 1 1
Neovascularization 1 1
Optical Nerve Damage 1 1
Rash 1 1
Local Reaction 1 1
Laceration(s) 1 1
Uveitis 1 1
Vitreous Hemorrhage 1 1
Phototoxicity 1 1
Chills 1 1
Dizziness 1 1
Hallucination 1 1
Epistaxis 1 1
Unspecified Respiratory Problem 1 1
Corneal Epithelial Microcysts 1 1

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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