Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 7
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BENQ MATERIALS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRUNO VISION CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 5
DK MEDIVISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
E.O.S CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOYA LAMPHUN , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HAIPUMING TECHNOLOGY CO., 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 7
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VISCO VISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
X-CEL SPECIALTY CONTACTS, A WALMAN OPTICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 117 123
2021 110 115
2022 126 150
2023 178 188
2024 297 297
2025 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 669 672
Improper or Incorrect Procedure or Method 49 49
Material Split, Cut or Torn 40 44
Insufficient Information 28 28
Patient-Device Incompatibility 27 27
Product Quality Problem 23 27
Use of Device Problem 22 22
Difficult to Remove 19 22
Break 10 27
Therapeutic or Diagnostic Output Failure 10 10
Patient Device Interaction Problem 8 8
Fitting Problem 7 7
Device Handling Problem 7 7
Defective Device 7 14
Material Deformation 6 6
Nonstandard Device 6 7
Entrapment of Device 5 22
Material Opacification 5 6
Device Markings/Labelling Problem 5 6
Material Twisted/Bent 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Inadequacy of Device Shape and/or Size 4 4
Contamination /Decontamination Problem 4 6
Device Contaminated During Manufacture or Shipping 3 4
Particulates 3 3
Material Puncture/Hole 3 3
Component Missing 3 3
Material Too Rigid or Stiff 3 3
Defective Component 3 4
Expiration Date Error 3 3
Microbial Contamination of Device 3 3
Sharp Edges 2 2
Unexpected Color 2 2
Contamination 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Open or Close 2 2
Physical Resistance/Sticking 2 2
Material Frayed 2 2
Tear, Rip or Hole in Device Packaging 1 1
No Apparent Adverse Event 1 1
Fungus in Device Environment 1 2
Thickening of Material 1 1
Device Unsafe to Use in Environment 1 1
Extra Components 1 1
Dent in Material 1 1
Material Discolored 1 1
Positioning Failure 1 1
Degraded 1 1
Failure to Clean Adequately 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 435 436
Eye Pain 331 335
Red Eye(s) 293 293
Blurred Vision 164 165
Foreign Body Sensation in Eye 153 155
Keratitis 137 138
Eye Infections 128 129
Dry Eye(s) 107 107
Conjunctivitis 103 103
Corneal Abrasion 95 95
Excessive Tear Production 92 92
Corneal Scar 92 92
Bacterial Infection 74 74
Eye Injury 63 65
Discomfort 56 57
Corneal Infiltrates 49 50
Local Reaction 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 50
Visual Impairment 41 44
Eye Burn 41 41
Swelling/ Edema 39 40
Visual Disturbances 39 40
Pain 38 39
Loss of Vision 38 38
Unspecified Eye / Vision Problem 34 34
Inflammation 33 33
Burning Sensation 32 32
Itching Sensation 28 28
Corneal Edema 26 26
Hypersensitivity/Allergic reaction 26 26
Headache 23 24
Purulent Discharge 22 22
Insufficient Information 21 21
Erosion 20 20
Acanthameba Keratitis 20 20
Unspecified Infection 20 21
Uveitis 18 18
No Clinical Signs, Symptoms or Conditions 16 25
Fungal Infection 15 15
Chemosis 13 13
Iritis 13 13
Irritation 12 12
Erythema 12 12
Neovascularization 11 11
Ulcer 11 12
Hypopyon 11 11
Foreign Body In Patient 10 14
Increased Sensitivity 10 10
Corneal Clouding/Hazing 9 10
No Code Available 8 9

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Oct-24-2025
2 Alcon Research LLC II Sep-30-2024
3 Chengdu Ai Qin E-commerce Co., Ltd II Jul-27-2020
4 Clerio Vision II Apr-05-2021
5 Clerio Vision II Jan-08-2021
6 CooperVision Inc. II Jul-27-2021
7 CooperVision, Inc. II Mar-23-2023
8 CooperVision, Inc. II Jan-24-2023
9 Johnson & Johnson Vision Care, Inc. II Jul-23-2025
10 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
-
-