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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
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
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 5
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 1
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
X-CEL SPECIALTY CONTACTS, A WALMAN OPTICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213983  Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydr ...
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 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 550 550
Improper or Incorrect Procedure or Method 38 38
Material Split, Cut or Torn 30 30
Insufficient Information 26 26
Product Quality Problem 21 21
Patient-Device Incompatibility 19 19
Use of Device Problem 19 19
Difficult to Remove 16 16
Break 10 10
Fitting Problem 7 7
Defective Device 7 7
Device Handling Problem 6 6
Patient Device Interaction Problem 6 6
Entrapment of Device 5 5
Nonstandard Device 5 5
Material Deformation 5 5
Material Opacification 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Markings/Labelling Problem 4 4
Material Twisted/Bent 4 4
Contamination /Decontamination Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Defective Component 3 3
Particulates 3 3
Difficult to Open or Close 2 2
Appropriate Term/Code Not Available 2 2
Unexpected Color 2 2
Sharp Edges 2 2
Component Missing 2 2
Material Too Rigid or Stiff 2 2
Microbial Contamination of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Expiration Date Error 2 2
Positioning Failure 1 1
Material Discolored 1 1
Contamination 1 1
Failure to Clean Adequately 1 1
Dent in Material 1 1
Positioning Problem 1 1
Wrong Label 1 1
Device Unsafe to Use in Environment 1 1
Material Puncture/Hole 1 1
Material Invagination 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Disintegration 1 1
Device Damaged Prior to Use 1 1
No Apparent Adverse Event 1 1
Crack 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 357 357
Eye Pain 269 269
Red Eye(s) 234 234
Blurred Vision 136 136
Foreign Body Sensation in Eye 131 131
Keratitis 117 117
Eye Infections 94 94
Conjunctivitis 79 79
Dry Eye(s) 78 78
Corneal Scar 76 76
Corneal Abrasion 73 73
Excessive Tear Production 65 65
Bacterial Infection 65 65
Eye Injury 54 54
Local Reaction 47 47
Discomfort 43 43
Corneal Infiltrates 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Pain 38 39
Visual Disturbances 35 35
Visual Impairment 35 35
Loss of Vision 34 34
Eye Burn 32 32
Swelling/ Edema 29 29
Burning Sensation 26 26
Inflammation 26 26
Itching Sensation 24 24
Unspecified Eye / Vision Problem 23 23
Corneal Edema 22 22
Purulent Discharge 20 20
Hypersensitivity/Allergic reaction 20 20
Insufficient Information 19 19
Headache 17 17
Unspecified Infection 17 18
Acanthameba Keratitis 14 14
Erosion 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Fungal Infection 12 12
Irritation 12 12
Neovascularization 11 11
Ulcer 11 11
Chemosis 11 11
Hypopyon 11 11
Uveitis 11 11
Erythema 11 11
Foreign Body In Patient 10 10
Increased Sensitivity 10 10
No Code Available 8 8
Corneal Clouding/Hazing 7 7
Iritis 7 7

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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