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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
Regulation Description Soft (hydrophilic) contact lens.
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 5
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BENQ MATERIALS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRUNO VISION CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOPERVISION. INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDIVISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOYA LAMPHUN LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HAIPUMING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVA VISION INC.
  SUBSTANTIALLY EQUIVALENT 4
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
LARGAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUCENS TECHNOLOGY CO., LTD.
  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 6
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 2
VIZIONFOCUS INC.
  SUBSTANTIALLY EQUIVALENT 2
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
X-CEL SPECIALTY CONTACTS, A WALMAN OPTICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 117 117
2021 109 109
2022 126 126
2023 179 179
2024 297 297
2025 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 597 597
Improper or Incorrect Procedure or Method 42 42
Material Split, Cut or Torn 36 36
Patient-Device Incompatibility 27 27
Insufficient Information 27 27
Use of Device Problem 21 21
Product Quality Problem 21 21
Difficult to Remove 17 17
Break 10 10
Therapeutic or Diagnostic Output Failure 10 10
Fitting Problem 7 7
Patient Device Interaction Problem 7 7
Defective Device 7 7
Material Deformation 6 6
Device Handling Problem 6 6
Nonstandard Device 6 6
Entrapment of Device 5 5
Material Opacification 5 5
Material Twisted/Bent 5 5
Device Markings/Labelling Problem 5 5
Contamination /Decontamination Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Particulates 3 3
Component Missing 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Defective Component 3 3
Device Contaminated During Manufacture or Shipping 3 3
Expiration Date Error 2 2
Contamination 2 2
Material Puncture/Hole 2 2
Microbial Contamination of Device 2 2
Appropriate Term/Code Not Available 2 2
Unexpected Color 2 2
Material Too Rigid or Stiff 2 2
Difficult to Open or Close 2 2
Physical Resistance/Sticking 2 2
Material Frayed 2 2
Sharp Edges 2 2
Tear, Rip or Hole in Device Packaging 1 1
No Apparent Adverse Event 1 1
Fungus in Device Environment 1 1
Thickening of Material 1 1
Extra Components 1 1
Device Unsafe to Use in Environment 1 1
Dent in Material 1 1
Material Discolored 1 1
Positioning Failure 1 1
Failure to Clean Adequately 1 1
Positioning Problem 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 391 391
Eye Pain 295 295
Red Eye(s) 256 256
Blurred Vision 149 149
Foreign Body Sensation in Eye 144 144
Keratitis 126 126
Eye Infections 113 113
Dry Eye(s) 95 95
Conjunctivitis 89 89
Corneal Scar 85 85
Corneal Abrasion 83 83
Excessive Tear Production 76 76
Bacterial Infection 72 72
Eye Injury 60 60
Discomfort 49 49
Local Reaction 47 47
Corneal Infiltrates 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Visual Impairment 39 39
Pain 38 39
Eye Burn 38 38
Loss of Vision 37 37
Visual Disturbances 36 36
Swelling/ Edema 34 34
Inflammation 32 32
Unspecified Eye / Vision Problem 29 29
Burning Sensation 29 29
Itching Sensation 26 26
Corneal Edema 23 23
Headache 23 23
Purulent Discharge 22 22
Insufficient Information 20 20
Hypersensitivity/Allergic reaction 20 20
Unspecified Infection 19 20
Erosion 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Acanthameba Keratitis 15 15
Uveitis 14 14
Fungal Infection 13 13
Irritation 12 12
Erythema 12 12
Chemosis 12 12
Neovascularization 11 11
Hypopyon 11 11
Ulcer 11 11
Foreign Body In Patient 10 10
Increased Sensitivity 10 10
Iritis 9 9
Corneal Clouding/Hazing 9 9
No Code Available 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Sep-30-2024
2 Chengdu Ai Qin E-commerce Co., Ltd II Jul-27-2020
3 Clerio Vision II Apr-05-2021
4 Clerio Vision II Jan-08-2021
5 CooperVision Inc. II Jul-27-2021
6 CooperVision, Inc. II Mar-23-2023
7 CooperVision, Inc. II Jan-24-2023
8 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
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