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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
ABB OPTICAL GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
ABBCONCISE OPTICAL GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED VISION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 18
ALDEN OPTICAL LABS., INC.
  SUBSTANTIALLY EQUIVALENT 3
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 4
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 7
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BENZ RESEARCH AND DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRIEN HOLDEN VISION PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
C & E GP SPECIALISTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIBA VISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CLEARLAB SG PTE, LTD
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD
  SUBSTANTIALLY EQUIVALENT 1
COOPER VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 16
COOPERVISION. INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDIVISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DREAMCON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EYEMED TECHNOLOGIES S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
EYEYON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRESTONE OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GELFLEX LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
GEO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOYA LAMPHUN LTD.
  SUBSTANTIALLY EQUIVALENT 1
I-CODI CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
I-SEE VISION TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 3
I-SEE VISION TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVA VISION INC.
  SUBSTANTIALLY EQUIVALENT 6
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU HORIEN CONTACT LENS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
JOOWON INNOVATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
METRO OPTICS OF AUSTIN, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEO VISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OCULUS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
OPTIXON INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYDEV LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 2
SAFILENS, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SEINOH OPTICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMART PERFORMER CORP. LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOFLEX LIMITED
  SUBSTANTIALLY EQUIVALENT 3
SOLOTICA
  SUBSTANTIALLY EQUIVALENT 1
SOUFLON PHARMACEUTICALS LTD
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SUPERVISION OPTIMAX SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
TANGIBLE SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 2
THE LAGADO CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE SEE CLEAR COMPANY, INC
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
UNILENS CORP., USA
  SUBSTANTIALLY EQUIVALENT 4
VASSEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 8
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 3
VISION SCIENCE CO LTD
  SUBSTANTIALLY EQUIVALENT 1
VISION SCIENCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISIONEERING TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
X-CEL CONTACTS, INC.
  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 5

MDR Year MDR Reports MDR Events
2014 178 178
2015 161 161
2016 193 193
2017 280 280
2018 257 257
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 865 865
Insufficient Information 226 226
No Apparent Adverse Event 211 211
Patient-Device Incompatibility 121 121
Improper or Incorrect Procedure or Method 77 77
Device Operates Differently Than Expected 67 67
Appropriate Term/Code Not Available 53 53
Torn Material 37 37
Difficult to Remove 33 33
Material Split, Cut or Torn 30 30
Use of Device Problem 28 28
Product Quality Problem 28 28
Break 27 27
Fitting Problem 15 15
Defective Device 13 13
Material Integrity Problem 13 13
Inadequacy of Device Shape and/or Size 11 11
Microbial Contamination of Device 10 10
Nonstandard Device 8 8
Sticking 8 8
Device Handling Problem 8 8
Patient Device Interaction Problem 7 7
Contamination 7 7
Material Deformation 7 7
Device Markings/Labelling Problem 7 7
Naturally Worn 7 7
Therapeutic or Diagnostic Output Failure 6 6
Material Opacification 6 6
Entrapment of Device 6 6
Device Expiration Issue 5 5
Defective Component 5 5
Unexpected Therapeutic Results 5 5
Contamination /Decontamination Problem 5 5
Particulates 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Expiration Date Error 4 4
Material Disintegration 4 4
Packaging Problem 4 4
Component Missing 4 4
Device Contamination with Chemical or Other Material 3 3
Device Emits Odor 3 3
Device Dislodged or Dislocated 3 3
Positioning Problem 3 3
Off-Label Use 3 3
Physical Resistance/Sticking 3 3
Device Contaminated During Manufacture or Shipping 3 3
Scratched Material 2 2
Sharp Edges 2 2
Material Discolored 2 2
Material Too Rigid or Stiff 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 769 769
Red Eye(s) 524 524
Pain 404 405
Keratitis 260 260
Eye Pain 215 215
Unspecified Infection 203 204
Blurred Vision 200 200
Discomfort 190 191
Bacterial Infection 189 189
Foreign Body Sensation in Eye 183 183
Irritation 178 178
Conjunctivitis 171 171
Corneal Abrasion 139 139
Corneal Scar 120 120
Excessive Tear Production 108 108
Dry Eye(s) 105 105
No Code Available 105 105
Corneal Infiltrates 102 102
Loss of Vision 90 90
Burning Sensation 81 81
Visual Impairment 80 80
Inflammation 77 77
Swelling 77 77
Eye Injury 77 77
Eye Infections 75 75
Itching Sensation 67 68
Discharge 65 65
Ulcer 58 58
Visual Disturbances 49 49
Corneal Edema 47 47
Local Reaction 42 42
Fungal Infection 41 41
Acanthameba Keratitis 40 40
Erythema 36 37
Iritis 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Eye Burn 31 31
Neovascularization 30 30
Hypersensitivity/Allergic reaction 29 29
Erosion 29 29
Headache 26 26
Uveitis 25 25
Hypopyon 24 24
Abscess 21 21
Scarring 20 20
Insufficient Information 19 19
Swelling/ Edema 19 19
No Known Impact Or Consequence To Patient 19 19
Scar Tissue 18 18
Unspecified Eye / Vision Problem 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical II Mar-13-2018
2 Bausch & Lomb Inc Irb II Nov-04-2015
3 CIBA Vision Puerto Rico, Inc. II Apr-13-2011
4 Chengdu Ai Qin E-commerce Co., Ltd II Jul-27-2020
5 Ciba Vision Corporation II Jun-25-2015
6 Clerio Vision II Apr-05-2021
7 Clerio Vision II Jan-08-2021
8 Cooper Vision Caribbean Corp. III Oct-24-2014
9 Cooper Vision Caribbean Corp. II Jan-03-2013
10 CooperVision Inc. II Jul-27-2021
11 CooperVision Inc. I Oct-14-2011
12 CooperVision, Inc. II Mar-23-2023
13 CooperVision, Inc. II Jan-24-2023
14 Coopervision Inc. I Jan-11-2012
15 Eyezone II Jan-11-2012
16 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
17 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
18 Johnson & Johnson Vision Care, Inc. II Aug-23-2018
19 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
20 Johnson & Johnson Vision Care, Inc. II May-17-2013
21 The See Clear Company II Mar-03-2017
22 Vistakon III Sep-18-2009
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