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 8
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BENQ MATERIALS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRUNO VISION CARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 3
DK MEDIVISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
E.O.S CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEO MEDICAL 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 2
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LARGAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUCENS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METRO OPTICS OF AUSTIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
UNICON OPTICAL CO., LTD.
  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
2021 110 115
2022 126 150
2023 178 188
2024 297 297
2025 217 217
2026 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 658 659
Material Split, Cut or Torn 42 44
Improper or Incorrect Procedure or Method 33 33
Difficult to Remove 22 22
Insufficient Device Problem Information 15 15
Use of Device Problem 9 9
Patient Device Interaction Problem 8 8
Contamination 7 7
Device Handling Problem 7 7
Defective Device 6 6
Fitting Problem 6 6
Material Twisted/Bent 5 5
Crack 5 5
Inadequacy of Device Shape and/or Size 5 5
Material Opacification 4 4
Material Deformation 4 4
Material Frayed 3 3
Nonstandard Device 3 3
Product Quality Problem 3 3
Material Too Rigid or Stiff 3 3
Break 3 3
Microbial Contamination of Device 3 3
Component Missing 2 2
Device Contaminated During Manufacture or Shipping 2 2
Extra Components 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Open or Close 2 2
Unexpected Color 2 2
Compatibility Problem 2 2
Entrapment of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Sharp Edges 2 2
Contamination /Decontamination Problem 1 1
Positioning Failure 1 1
Expiration Date Error 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Puncture/Hole 1 1
Physical Resistance/Sticking 1 1
Defective Component 1 1
Thickening of Material 1 1
No Apparent Adverse Event 1 1
Difficult to Fold, Unfold or Collapse 1 1
Patient-Device Incompatibility 1 1
Scratched Material 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Failure to Clean Adequately 1 1
Material Discolored 1 1
Dent in Material 1 1
Material Invagination 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 469 470
Eye Pain 379 383
Red Eye(s) 311 311
Eye Irritation 204 204
Blurred Vision 183 183
Foreign Body Sensation in Eye 166 168
Eye Infections 149 150
Keratitis 130 131
Conjunctivitis 113 113
Corneal Abrasion 111 111
Dry Eye(s) 109 109
Corneal Scar 107 107
Excessive Tear Production 101 101
Photophobia 77 77
Bacterial Infection 69 69
Eye Injury 61 62
Discomfort 57 58
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 57 61
Corneal Infiltrates 50 51
Local Reaction 47 47
Visual Disturbances 46 47
Swelling/ Edema 46 47
Eye Burn 45 45
Loss of Vision 41 41
Unspecified Eye / Vision Problem 39 39
Burning Sensation 39 39
Itching Sensation 31 31
Corneal Edema 30 30
Inflammation 29 29
Visual Impairment 28 29
Hypersensitivity/Allergic reaction 24 24
Infective Keratitis 23 23
Erosion 23 23
Insufficient Information 22 22
Purulent Discharge 22 22
Headache 20 21
No Clinical Signs, Symptoms or Conditions 19 28
Uveitis 18 18
Iritis 16 16
Chemosis 14 14
Pain 14 14
Fungal Infection 14 14
Unspecified Infection 13 13
Corneal Clouding/Hazing 11 12
Hyperresponsive to stimuli 10 10
Hypopyon 10 10
Foreign Body In Patient 10 14
Erythema 9 9
Neovascularization 8 8
Fluid Discharge 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Oct-24-2025
2 Alcon Research LLC II Sep-30-2024
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 Mar-23-2023
7 CooperVision, Inc. II Jan-24-2023
8 Johnson & Johnson Vision Care, Inc. II Jul-23-2025
9 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
-
-