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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lenses, soft contact, daily wear
Product CodeLPL
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
CLEARLAB SG PTE, LTD
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOPERVISION. INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDIVISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EYEMED TECHNOLOGIES S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
HOYA LAMPHUN LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVA VISION INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
LARGAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LENTECHS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METRO OPTICS OF AUSTIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTIXON INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 204 204
2020 117 117
2021 109 109
2022 126 126
2023 179 179
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 520 520
Patient-Device Incompatibility 39 39
Improper or Incorrect Procedure or Method 38 38
Material Split, Cut or Torn 25 25
Product Quality Problem 24 24
Use of Device Problem 19 19
Insufficient Information 16 16
Break 15 15
Difficult to Remove 10 10
Fitting Problem 10 10
Appropriate Term/Code Not Available 9 9
Defective Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Nonstandard Device 6 6
Patient Device Interaction Problem 6 6
Contamination /Decontamination Problem 4 4
Device Markings/Labelling Problem 4 4
Defective Component 4 4
Material Deformation 3 3
Material Opacification 3 3
Particulates 3 3
Entrapment of Device 3 3
Device Handling Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 2 2
Labelling, Instructions for Use or Training Problem 2 2
Off-Label Use 2 2
Material Disintegration 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Expiration Date Error 2 2
Device Damaged Prior to Use 1 1
Dent in Material 1 1
Material Integrity Problem 1 1
Device Unsafe to Use in Environment 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Too Rigid or Stiff 1 1
Material Puncture/Hole 1 1
Material Invagination 1 1
Difficult to Fold, Unfold or Collapse 1 1
Contamination 1 1
Crack 1 1
Material Discolored 1 1
Wrong Label 1 1
Migration 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 314 314
Red Eye(s) 197 197
Eye Pain 156 156
Keratitis 119 119
Foreign Body Sensation in Eye 106 106
Pain 98 99
Corneal Scar 84 84
Blurred Vision 81 81
Conjunctivitis 68 68
Bacterial Infection 63 63
Dry Eye(s) 62 62
Eye Infections 60 60
Excessive Tear Production 59 59
Discomfort 57 57
Corneal Abrasion 52 52
Eye Injury 49 49
Corneal Infiltrates 45 45
Visual Impairment 41 41
Loss of Vision 41 41
Irritation 41 41
Visual Disturbances 36 36
Local Reaction 35 35
Burning Sensation 34 34
Unspecified Infection 32 33
Inflammation 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
No Code Available 24 24
Itching Sensation 22 22
Corneal Edema 21 21
Eye Burn 19 19
Swelling 16 16
Swelling/ Edema 15 15
Ulcer 14 14
Fungal Infection 14 14
Neovascularization 14 14
Uveitis 13 13
Headache 13 13
Erythema 13 13
Discharge 12 12
Unspecified Eye / Vision Problem 12 12
Insufficient Information 11 11
Hypersensitivity/Allergic reaction 11 11
Acanthameba Keratitis 10 10
Iritis 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Hypopyon 9 9
Purulent Discharge 8 8
Erosion 8 8
Scarring 8 8
Increased Sensitivity 8 8
No Known Impact Or Consequence To Patient 7 7
Corneal Clouding/Hazing 7 7
Abscess 6 6
Cellulitis 6 6
Intraocular Infection 5 5
Increased Sensitivity 5 5
Corneal Stromal Edema 4 4
Endophthalmitis 4 4
Chemosis 4 4
Glaucoma 3 3
Hypoxia 3 3
Intraocular Pressure Increased 3 3
Ulceration 3 3
Device Embedded In Tissue or Plaque 3 3
Viral Infection 3 3
Foreign Body In Patient 3 3
Skin Inflammation/ Irritation 2 2
Sexually Transmitted Infection 2 2
Irritability 2 2
Fluid Discharge 2 2
Chemical Exposure 2 2
Injury 2 2
Tingling 2 2
Dizziness 2 2
Laceration(s) 2 2
Retinal Degeneration 2 2
Scar Tissue 2 2
Rash 2 2
Corneal Decompensation 2 2
Edema 2 2
Corneal Perforation 1 1
Deposits 1 1
Anaphylactic Shock 1 1
Cataract, Induced 1 1
Hemorrhage/Bleeding 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Fungus 1 1
Vitreous Floaters 1 1
Foreign Body Reaction 1 1
Skin Irritation 1 1
Occlusion 1 1
Anaphylactoid 1 1
Thrombosis 1 1
Halo 1 1
Clouding, Central Corneal 1 1
Microcysts, Epithelial 1 1
Coma 1 1
Tissue Breakdown 1 1
Low Oxygen Saturation 1 1
Sleep Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Chengdu Ai Qin E-commerce Co., Ltd II Jul-27-2020
2 Clerio Vision II Apr-05-2021
3 Clerio Vision II Jan-08-2021
4 CooperVision Inc. II Jul-27-2021
5 CooperVision, Inc. II Mar-23-2023
6 CooperVision, Inc. II Jan-24-2023
7 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
8 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
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