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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 9
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CLEARLAB SG PTE, LTD
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOPERVISION. INC.
  SUBSTANTIALLY EQUIVALENT 1
EYEMED TECHNOLOGIES S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GELFLEX LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
LARGAN MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 2
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYDEV LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 1
SUPERVISION OPTIMAX SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
TANGIBLE SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 2
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 6
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 2
VISIONEERING TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 280 280
2018 257 257
2019 204 204
2020 117 117
2021 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 450 450
No Apparent Adverse Event 149 149
Patient-Device Incompatibility 85 85
Insufficient Information 70 70
Improper or Incorrect Procedure or Method 40 40
Appropriate Term/Code Not Available 37 37
Product Quality Problem 15 15
Difficult to Remove 14 14
Device Operates Differently Than Expected 14 14
Break 13 13
Material Split, Cut or Torn 13 13
Torn Material 13 13
Use of Device Problem 10 10
Fitting Problem 8 8
Inadequacy of Device Shape and/or Size 7 7
Defective Device 6 6
Device Markings/Labelling Problem 5 5
Contamination 5 5
Defective Component 4 4
Microbial Contamination of Device 4 4
Material Integrity Problem 4 4
Positioning Problem 3 3
Physical Resistance/Sticking 3 3
Off-Label Use 3 3
Expiration Date Error 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Device Contamination with Chemical or Other Material 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Device Expiration Issue 2 2
Labelling, Instructions for Use or Training Problem 2 2
Nonstandard Device 2 2
Component Missing 2 2
Sticking 2 2
Sharp Edges 2 2
Therapeutic or Diagnostic Output Failure 2 2
Scratched Material 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Device Fell 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Shelf Life Exceeded 1 1
Fungus in Device Environment 1 1
Material Opacification 1 1
Material Puncture/Hole 1 1
Detachment Of Device Component 1 1
Incorrect Device Or Component Shipped 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Detachment of Device or Device Component 1 1
Device Displays Incorrect Message 1 1
Folded 1 1
Failure To Adhere Or Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 347 347
Pain 241 242
Red Eye(s) 231 231
Keratitis 126 126
Discomfort 122 122
Bacterial Infection 115 115
Irritation 110 110
Unspecified Infection 97 98
Conjunctivitis 93 93
Blurred Vision 74 74
No Code Available 65 65
Corneal Scar 61 61
Foreign Body Sensation in Eye 58 58
Visual Impairment 55 55
Dry Eye(s) 54 54
Swelling 52 52
Corneal Abrasion 50 50
Excessive Tear Production 50 50
Burning Sensation 49 49
Corneal Infiltrates 47 47
Ulcer 45 45
Discharge 40 40
Inflammation 40 40
Loss of Vision 37 37
Itching Sensation 36 36
Eye Injury 32 32
Eye Pain 30 30
Fungal Infection 27 27
Visual Disturbances 25 25
Erythema 22 22
Corneal Edema 20 20
Acanthameba Keratitis 20 20
No Known Impact Or Consequence To Patient 15 15
Abscess 14 14
Headache 13 13
Neovascularization 13 13
Scarring 13 13
Uveitis 12 12
Iritis 12 12
Hypopyon 12 12
Hypersensitivity/Allergic reaction 11 11
Erosion 11 11
Local Reaction 10 10
Increased Sensitivity 9 9
Tingling 8 8
Reaction 7 7
Ulceration 6 6
Cellulitis 6 6
Edema 6 6
Fungus 5 5
Eye Infections 5 5
Insufficient Information 4 4
Foreign Body In Patient 4 4
Microcysts, Epithelial 4 4
Injury 4 4
Abrasion 4 4
Corneal Decompensation 4 4
Scar Tissue 4 4
Hypoxia 4 4
Intraocular Infection 3 3
Laceration(s) 3 3
Chemosis 3 3
Glaucoma 3 3
Herpes 3 3
Endophthalmitis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 3 3
Fluid Discharge 2 2
Eye Burn 2 2
Caustic/Chemical Burns 2 2
Chemical Exposure 2 2
Viral Infection 2 2
Corneal Stromal Edema 2 2
Hyperemia 2 2
Hemorrhage/Bleeding 2 2
Corneal Perforation 2 2
Purulent Discharge 2 2
Staphylococcus Aureus 2 2
Skin Irritation 1 1
Thrombosis 1 1
Phototoxicity 1 1
Occlusion 1 1
Rash 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1
Deposits 1 1
Cataract 1 1
Cataract, Induced 1 1
Corneal Clouding/Hazing 1 1
Fatigue 1 1
Vitreous Floaters 1 1
Foreign Body Reaction 1 1
Dizziness 1 1
Rupture 1 1
Halo 1 1
Clouding, Central Corneal 1 1
Complaint, Ill-Defined 1 1
Irritability 1 1
Encephalitis 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 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
7 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
8 Johnson & Johnson Vision Care, Inc. II Aug-23-2018
9 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
10 The See Clear Company II Mar-03-2017
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