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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 8
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
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
GELFLEX LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
INNOVA VISION INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
LARGAN MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
LARGAN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LARGAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LENTECHS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OPTIXON INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUPERVISION OPTIMAX SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 5
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 2
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 257 257
2019 204 204
2020 117 117
2021 109 109
2022 126 126

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 481 481
Patient-Device Incompatibility 67 67
No Apparent Adverse Event 60 60
Improper or Incorrect Procedure or Method 41 41
Insufficient Information 27 27
Appropriate Term/Code Not Available 22 22
Product Quality Problem 17 17
Break 16 16
Material Split, Cut or Torn 15 15
Difficult to Remove 12 12
Fitting Problem 9 9
Use of Device Problem 9 9
Defective Device 7 7
Inadequacy of Device Shape and/or Size 6 6
Device Markings/Labelling Problem 5 5
Device Operates Differently Than Expected 4 4
Defective Component 4 4
Nonstandard Device 4 4
Contamination 4 4
Patient Device Interaction Problem 4 4
Expiration Date Error 4 4
Physical Resistance/Sticking 3 3
Therapeutic or Diagnostic Output Failure 3 3
Torn Material 3 3
Material Integrity Problem 3 3
Entrapment of Device 3 3
Contamination /Decontamination Problem 3 3
Microbial Contamination of Device 2 2
Component Missing 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Disintegration 2 2
Material Opacification 2 2
Off-Label Use 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Sharp Edges 2 2
Device Fell 1 1
Device Handling Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Migration 1 1
Material Puncture/Hole 1 1
Sticking 1 1
Shelf Life Exceeded 1 1
Failure To Adhere Or Bond 1 1
Device Expiration Issue 1 1
Crack 1 1
Material Discolored 1 1
Device Damaged Prior to Use 1 1
Fungus in Device Environment 1 1
Dent in Material 1 1
Detachment of Device or Device Component 1 1
Device Displays Incorrect Message 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 307 307
Red Eye(s) 192 192
Pain 172 173
Keratitis 104 104
Discomfort 85 85
Eye Pain 78 78
Bacterial Infection 78 78
Corneal Scar 76 76
Irritation 74 74
Foreign Body Sensation in Eye 71 71
Conjunctivitis 70 70
Blurred Vision 64 64
Unspecified Infection 57 58
Visual Impairment 52 52
Excessive Tear Production 51 51
Dry Eye(s) 50 50
Corneal Infiltrates 44 44
No Code Available 43 43
Corneal Abrasion 43 43
Loss of Vision 40 40
Burning Sensation 37 37
Inflammation 37 37
Visual Disturbances 32 32
Swelling 31 31
Eye Injury 31 31
Ulcer 27 27
Fungal Infection 23 23
Itching Sensation 23 23
Local Reaction 22 22
Eye Infections 22 22
Discharge 20 20
Acanthameba Keratitis 18 18
Corneal Edema 18 18
Erythema 15 15
Uveitis 14 14
Headache 13 13
Neovascularization 13 13
No Known Impact Or Consequence To Patient 12 12
Hypopyon 11 11
Abscess 11 11
Iritis 10 10
Scarring 8 8
Hypersensitivity/Allergic reaction 8 8
Cellulitis 7 7
Erosion 7 7
Increased Sensitivity 7 7
Eye Burn 6 6
Swelling/ Edema 6 6
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Ulceration 5 5
Corneal Clouding/Hazing 5 5
Edema 4 4
Corneal Decompensation 4 4
Tingling 4 4
Hypoxia 4 4
Intraocular Infection 4 4
Scar Tissue 3 3
Purulent Discharge 3 3
Endophthalmitis 3 3
Glaucoma 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Device Embedded In Tissue or Plaque 3 3
Viral Infection 3 3
Reaction 3 3
Foreign Body In Patient 3 3
Sexually Transmitted Infection 2 2
Halo 2 2
Microcysts, Epithelial 2 2
Injury 2 2
Fluid Discharge 2 2
Caustic/Chemical Burns 2 2
Chemical Exposure 2 2
Unspecified Eye / Vision Problem 2 2
Fungus 2 2
Hemorrhage/Bleeding 2 2
Corneal Stromal Edema 2 2
Abrasion 2 2
Chemosis 2 2
Laceration(s) 2 2
Occlusion 1 1
Rash 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1
Thrombosis 1 1
Skin Irritation 1 1
Staphylococcus Aureus 1 1
Dizziness 1 1
Rupture 1 1
Anaphylactic Shock 1 1
Cataract 1 1
Cataract, Induced 1 1
Deposits 1 1
Corneal Perforation 1 1
Fatigue 1 1
Vitreous Floaters 1 1
Foreign Body Reaction 1 1
Skin Inflammation/ Irritation 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical II Mar-13-2018
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 Jan-24-2023
7 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
8 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
9 Johnson & Johnson Vision Care, Inc. II Aug-23-2018
10 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
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