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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 4
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 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 3
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 584 584
Improper or Incorrect Procedure or Method 43 43
Patient-Device Incompatibility 39 39
Material Split, Cut or Torn 27 27
Insufficient Information 25 25
Product Quality Problem 24 24
Use of Device Problem 19 19
Break 15 15
Difficult to Remove 13 13
Fitting Problem 10 10
Appropriate Term/Code Not Available 9 9
Defective Device 8 8
Inadequacy of Device Shape and/or Size 7 7
Patient Device Interaction Problem 7 7
Nonstandard Device 6 6
Entrapment of Device 5 5
Device Handling Problem 4 4
Device Markings/Labelling Problem 4 4
Contamination /Decontamination Problem 4 4
Defective Component 4 4
Material Deformation 3 3
Particulates 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Opacification 3 3
Device Contaminated During Manufacture or Shipping 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Expiration Date Error 2 2
Contamination 2 2
Microbial Contamination of Device 2 2
Material Too Rigid or Stiff 2 2
Component Missing 2 2
Material Twisted/Bent 2 2
Material Disintegration 2 2
Sharp Edges 2 2
Physical Resistance/Sticking 2 2
Labelling, Instructions for Use or Training Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Off-Label Use 2 2
Fungus in Device Environment 2 2
Material Integrity Problem 1 1
Positioning Problem 1 1
Failure to Clean Adequately 1 1
Wrong Label 1 1
Material Puncture/Hole 1 1
Material Invagination 1 1
Material Discolored 1 1
Difficult to Fold, Unfold or Collapse 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Device Unsafe to Use in Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 355 355
Red Eye(s) 235 235
Eye Pain 215 215
Foreign Body Sensation in Eye 129 129
Keratitis 129 129
Blurred Vision 115 115
Pain 100 101
Corneal Scar 91 91
Conjunctivitis 84 84
Eye Infections 75 75
Bacterial Infection 73 73
Dry Eye(s) 72 72
Excessive Tear Production 65 65
Corneal Abrasion 64 64
Discomfort 63 63
Eye Injury 54 54
Corneal Infiltrates 50 50
Loss of Vision 44 44
Visual Impairment 43 43
Irritation 41 41
Local Reaction 41 41
Visual Disturbances 39 39
Burning Sensation 35 35
Unspecified Infection 34 35
Inflammation 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Itching Sensation 27 27
Eye Burn 27 27
No Code Available 24 24
Corneal Edema 23 23
Swelling/ Edema 19 19
Insufficient Information 19 19
Fungal Infection 18 18
Unspecified Eye / Vision Problem 18 18
Hypersensitivity/Allergic reaction 18 18
Swelling 16 16
Headache 15 15
Neovascularization 15 15
Ulcer 14 14
Uveitis 14 14
Erosion 13 13
Purulent Discharge 13 13
Erythema 13 13
Acanthameba Keratitis 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Discharge 12 12
Iritis 10 10
Foreign Body In Patient 10 10
Hypopyon 9 9
Corneal Clouding/Hazing 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
9 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
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