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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
2018 95 95
2019 60 60
2020 82 82
2021 50 50
2022 62 62
2023 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 171 171
Product Quality Problem 38 38
Device Markings/Labelling Problem 35 35
Contamination 30 30
Device Emits Odor 27 27
Patient-Device Incompatibility 24 24
Improper or Incorrect Procedure or Method 21 21
Labelling, Instructions for Use or Training Problem 13 13
Insufficient Information 13 13
Contamination /Decontamination Problem 8 8
Use of Device Problem 7 7
Device Handling Problem 6 6
Material Integrity Problem 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
No Apparent Adverse Event 4 4
Contamination of Device Ingredient or Reagent 4 4
Microbial Contamination of Device 3 3
Improper Chemical Reaction 3 3
Output Problem 3 3
Nonstandard Device 3 3
Fluid/Blood Leak 3 3
Defective Device 3 3
Break 2 2
Off-Label Use 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Chemical Problem 2 2
Device Ingredient or Reagent Problem 1 1
Expiration Date Error 1 1
Inadequate User Interface 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Defective Component 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Device Reprocessing Problem 1 1
Failure to Disinfect 1 1
Accessory Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 113 113
Red Eye(s) 68 68
Pain 66 66
Discomfort 44 44
Blurred Vision 43 43
Corneal Ulcer 42 42
Eye Burn 37 37
Irritation 34 34
Eye Pain 34 34
Keratitis 30 30
Excessive Tear Production 29 29
No Known Impact Or Consequence To Patient 26 26
Corneal Abrasion 25 25
No Clinical Signs, Symptoms or Conditions 24 24
Eye Infections 21 21
Dry Eye(s) 21 21
Corneal Scar 19 19
Conjunctivitis 17 17
Erythema 17 17
Loss of Vision 17 17
Swelling 16 16
Eye Injury 16 16
Hyperemia 16 16
Inflammation 15 15
Unspecified Infection 14 14
Itching Sensation 13 13
Corneal Edema 13 13
Foreign Body Sensation in Eye 12 12
Headache 12 12
Visual Impairment 12 12
No Code Available 12 12
Visual Disturbances 11 11
Caustic/Chemical Burns 10 10
Corneal Infiltrates 9 9
Swelling/ Edema 9 9
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Fungal Infection 7 7
Reaction 6 6
Discharge 6 6
Corneal Clouding/Hazing 6 6
Purulent Discharge 6 6
Erosion 5 5
Acanthameba Keratitis 5 5
Increased Sensitivity 5 5
Unspecified Eye / Vision Problem 5 5
Patient Problem/Medical Problem 5 5
Skin Inflammation/ Irritation 4 4
Fluid Discharge 4 4
Distress 4 4
Hypersensitivity/Allergic reaction 4 4
Intraocular Infection 3 3
Skin Irritation 3 3
Dizziness 3 3
Overwear Syndrome 3 3
Nausea 3 3
Foreign Body In Patient 3 3
Ptosis 2 2
Neovascularization 2 2
Skin Discoloration 2 2
Ulcer 2 2
Injury 2 2
Iritis 2 2
Hemorrhage/Bleeding 2 2
Bacterial Infection 2 2
Vitreous Floaters 2 2
Edema 1 1
Endophthalmitis 1 1
Exposure to Body Fluids 1 1
Abdominal Pain 1 1
Abscess 1 1
Burn(s) 1 1
Chemosis 1 1
Hypopyon 1 1
Laceration(s) 1 1
Miscarriage 1 1
Ischemia 1 1
Chemical Exposure 1 1
Weight Changes 1 1
No Consequences Or Impact To Patient 1 1
Halo 1 1
Scarring 1 1
Optical Nerve Damage 1 1
Local Reaction 1 1
Vitreous Hemorrhage 1 1
Phototoxicity 1 1
Chills 1 1
Uveitis 1 1
No Patient Involvement 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Localized Skin Lesion 1 1
Hallucination 1 1
Epistaxis 1 1
Unspecified Respiratory Problem 1 1
Corneal Epithelial Microcysts 1 1
Contact Dermatitis 1 1
Nodule 1 1
Reaction to Medicinal Component of Device 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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