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
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 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 7
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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 635 637
Material Split, Cut or Torn 45 49
Improper or Incorrect Procedure or Method 44 44
Difficult to Remove 23 26
Insufficient Information 22 22
Product Quality Problem 21 24
Patient-Device Incompatibility 21 21
Use of Device Problem 18 18
Patient Device Interaction Problem 16 16
Therapeutic or Diagnostic Output Failure 10 10
Break 8 25
Defective Device 8 15
Device Handling Problem 7 7
Contamination 7 7
Fitting Problem 6 6
Nonstandard Device 6 7
Entrapment of Device 6 23
Crack 6 9
Material Deformation 6 6
Inadequacy of Device Shape and/or Size 5 5
Material Twisted/Bent 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Opacification 4 4
Particulates 3 3
Component Missing 3 3
Material Too Rigid or Stiff 3 3
Contamination /Decontamination Problem 3 3
Microbial Contamination of Device 3 3
Expiration Date Error 3 3
Material Puncture/Hole 3 3
Device Markings/Labelling Problem 3 3
Device Contaminated During Manufacture or Shipping 3 4
Material Frayed 3 3
Sharp Edges 2 2
Unexpected Color 2 2
Tear, Rip or Hole in Device Packaging 2 2
Appropriate Term/Code Not Available 2 2
Compatibility Problem 2 2
Difficult to Open or Close 2 2
Extra Components 2 2
Failure to Clean Adequately 1 1
Defective Component 1 1
Scratched Material 1 1
Wrong Label 1 8
Degraded 1 1
Material Invagination 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Disintegration 1 2
Positioning Failure 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 434 435
Eye Pain 357 361
Red Eye(s) 291 291
Blurred Vision 166 166
Foreign Body Sensation in Eye 160 162
Eye Infections 134 135
Keratitis 121 122
Conjunctivitis 105 105
Corneal Abrasion 104 104
Dry Eye(s) 100 100
Excessive Tear Production 95 95
Corneal Scar 95 95
Bacterial Infection 67 67
Eye Injury 58 59
Discomfort 50 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 53
Local Reaction 47 47
Corneal Infiltrates 46 47
Visual Disturbances 44 45
Eye Burn 43 43
Swelling/ Edema 41 42
Loss of Vision 36 36
Unspecified Eye / Vision Problem 36 36
Burning Sensation 34 34
Corneal Edema 28 28
Itching Sensation 27 27
Inflammation 27 27
Visual Impairment 24 25
Purulent Discharge 22 22
Hypersensitivity/Allergic reaction 22 22
Erosion 22 22
Acanthameba Keratitis 21 21
Insufficient Information 21 21
Headache 19 20
Uveitis 17 17
No Clinical Signs, Symptoms or Conditions 17 26
Iritis 15 15
Fungal Infection 14 14
Pain 14 14
Chemosis 13 13
Unspecified Infection 12 12
Increased Sensitivity 10 10
Foreign Body In Patient 10 14
Corneal Clouding/Hazing 9 10
Hypopyon 9 9
Neovascularization 8 8
Erythema 8 8
Fluid Discharge 6 6
Ulcer 5 6
Intraocular Infection 5 5

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
-
-