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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 10
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
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 3
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYDEV LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  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
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 280 280
2018 257 257
2019 204 204
2020 117 117
2021 109 109
2022 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 512 512
No Apparent Adverse Event 150 150
Patient-Device Incompatibility 87 87
Insufficient Information 72 72
Improper or Incorrect Procedure or Method 42 42
Appropriate Term/Code Not Available 37 37
Difficult to Remove 18 18
Product Quality Problem 17 17
Break 16 16
Device Operates Differently Than Expected 14 14
Material Split, Cut or Torn 14 14
Torn Material 13 13
Use of Device Problem 13 13
Fitting Problem 10 10
Inadequacy of Device Shape and/or Size 7 7
Defective Device 6 6
Device Markings/Labelling Problem 5 5
Contamination 5 5
Entrapment of Device 4 4
Nonstandard Device 4 4
Expiration Date Error 4 4
Defective Component 4 4
Microbial Contamination of Device 4 4
Material Deformation 4 4
Material Integrity Problem 4 4
Positioning Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Physical Resistance/Sticking 3 3
Contamination /Decontamination Problem 3 3
Off-Label Use 3 3
Sticking 2 2
Device Expiration Issue 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Disintegration 2 2
Component Missing 2 2
Sharp Edges 2 2
Device Contamination with Chemical or Other Material 2 2
Incorrect Device Or Component Shipped 1 1
Packaging Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Scratched Material 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Device Fell 1 1
Fungus in Device Environment 1 1
Device Displays Incorrect Message 1 1
Folded 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Failure To Adhere Or Bond 1 1
Crack 1 1
Detachment Of Device Component 1 1
Shelf Life Exceeded 1 1
Material Puncture/Hole 1 1
Material Opacification 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 383 383
Red Eye(s) 250 250
Pain 242 243
Keratitis 134 134
Bacterial Infection 125 125
Discomfort 124 124
Irritation 110 110
Conjunctivitis 102 102
Unspecified Infection 97 98
Blurred Vision 79 79
Foreign Body Sensation in Eye 77 77
Corneal Scar 72 72
No Code Available 65 65
Eye Pain 61 61
Dry Eye(s) 61 61
Visual Impairment 57 57
Corneal Abrasion 55 55
Excessive Tear Production 53 53
Swelling 52 52
Burning Sensation 51 51
Corneal Infiltrates 50 50
Ulcer 46 46
Loss of Vision 44 44
Inflammation 43 43
Discharge 40 40
Itching Sensation 38 38
Eye Injury 36 36
Visual Disturbances 31 31
Fungal Infection 28 28
Erythema 22 22
Acanthameba Keratitis 20 20
Corneal Edema 20 20
Local Reaction 18 18
Neovascularization 15 15
No Known Impact Or Consequence To Patient 15 15
Abscess 14 14
Headache 14 14
Hypopyon 13 13
Scarring 13 13
Eye Infections 13 13
Uveitis 12 12
Iritis 12 12
Hypersensitivity/Allergic reaction 11 11
Erosion 11 11
Increased Sensitivity 9 9
Tingling 8 8
Reaction 7 7
Cellulitis 7 7
Edema 6 6
Ulceration 6 6
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Swelling/ Edema 5 5
Eye Burn 5 5
Foreign Body In Patient 5 5
Scar Tissue 5 5
Intraocular Infection 5 5
Fungus 5 5
Endophthalmitis 4 4
Corneal Decompensation 4 4
Abrasion 4 4
Hypoxia 4 4
Injury 4 4
Microcysts, Epithelial 4 4
Device Embedded In Tissue or Plaque 3 3
Laceration(s) 3 3
Chemosis 3 3
Glaucoma 3 3
Herpes 3 3
Hyperemia 2 2
Hemorrhage/Bleeding 2 2
Corneal Clouding/Hazing 2 2
Purulent Discharge 2 2
Corneal Stromal Edema 2 2
Corneal Perforation 2 2
Staphylococcus Aureus 2 2
Unspecified Eye / Vision Problem 2 2
Fluid Discharge 2 2
Caustic/Chemical Burns 2 2
Chemical Exposure 2 2
Viral Infection 2 2
Sexually Transmitted Infection 2 2
No Clinical Signs, Symptoms or Conditions 2 2
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
Sleep Dysfunction 1 1
Tissue Breakdown 1 1
Coma 1 1
Skin Inflammation/ Irritation 1 1
No Information 1 1
Patient Problem/Medical Problem 1 1
Skin Irritation 1 1
Thrombosis 1 1
Phototoxicity 1 1
Occlusion 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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