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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 299 299
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 535 535
Improper or Incorrect Procedure or Method 38 38
Material Split, Cut or Torn 30 30
Insufficient Information 26 26
Product Quality Problem 21 21
Use of Device Problem 19 19
Patient-Device Incompatibility 19 19
Difficult to Remove 16 16
Break 12 12
Fitting Problem 7 7
Defective Device 7 7
Device Handling Problem 6 6
Patient Device Interaction Problem 6 6
Entrapment of Device 5 5
Material Deformation 5 5
Nonstandard Device 5 5
Material Twisted/Bent 4 4
Contamination /Decontamination Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Markings/Labelling Problem 4 4
Material Opacification 4 4
Particulates 3 3
Defective Component 3 3
Device Contaminated During Manufacture or Shipping 3 3
Sharp Edges 2 2
Expiration Date Error 2 2
Appropriate Term/Code Not Available 2 2
Unexpected Color 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Too Rigid or Stiff 2 2
Microbial Contamination of Device 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Open or Close 2 2
Physical Resistance/Sticking 1 1
Device Unsafe to Use in Environment 1 1
Material Disintegration 1 1
Material Puncture/Hole 1 1
Difficult to Fold, Unfold or Collapse 1 1
Positioning Problem 1 1
Positioning Failure 1 1
No Apparent Adverse Event 1 1
Failure to Clean Adequately 1 1
Fungus in Device Environment 1 1
Off-Label Use 1 1
Crack 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Extra Components 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 352 352
Eye Pain 263 263
Red Eye(s) 227 227
Blurred Vision 136 136
Foreign Body Sensation in Eye 129 129
Keratitis 116 116
Eye Infections 90 90
Dry Eye(s) 77 77
Conjunctivitis 75 75
Corneal Scar 73 73
Corneal Abrasion 71 71
Excessive Tear Production 63 63
Bacterial Infection 60 60
Eye Injury 52 52
Local Reaction 47 47
Discomfort 43 43
Corneal Infiltrates 39 39
Pain 38 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Visual Disturbances 35 35
Visual Impairment 34 34
Loss of Vision 33 33
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
Unspecified Infection 17 18
Headache 17 17
Erosion 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Acanthameba Keratitis 14 14
Irritation 12 12
Fungal Infection 12 12
Uveitis 11 11
Neovascularization 11 11
Chemosis 11 11
Ulcer 11 11
Erythema 11 11
Foreign Body In Patient 10 10
Increased Sensitivity 10 10
Hypopyon 9 9
No Code Available 8 8
Iritis 7 7
Corneal Clouding/Hazing 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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