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
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 6
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH + LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
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
HOYA LAMPHUN 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 1
LENTECHS, LLC
  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 5
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO VISION INC
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZIONFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VP OPTICS
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 204 204
2020 117 117
2021 109 109
2022 126 126
2023 179 179
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 561 561
Improper or Incorrect Procedure or Method 42 42
Patient-Device Incompatibility 39 39
Material Split, Cut or Torn 25 25
Product Quality Problem 24 24
Use of Device Problem 19 19
Insufficient Information 16 16
Break 15 15
Difficult to Remove 10 10
Fitting Problem 10 10
Appropriate Term/Code Not Available 9 9
Defective Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Nonstandard Device 6 6
Patient Device Interaction Problem 6 6
Entrapment of Device 5 5
Defective Component 4 4
Contamination /Decontamination Problem 4 4
Device Markings/Labelling Problem 4 4
Device Handling Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Deformation 3 3
Material Opacification 3 3
Particulates 3 3
Off-Label Use 2 2
Material Disintegration 2 2
Labelling, Instructions for Use or Training Problem 2 2
Contamination 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Microbial Contamination of Device 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Expiration Date Error 2 2
Material Twisted/Bent 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 2 2
Unexpected Color 1 1
Wrong Label 1 1
Migration 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Device Damaged Prior to Use 1 1
Dent in Material 1 1
Material Integrity Problem 1 1
Device Unsafe to Use in Environment 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Crack 1 1
Material Discolored 1 1
Material Invagination 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Too Rigid or Stiff 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 343 343
Red Eye(s) 222 222
Eye Pain 188 188
Keratitis 126 126
Foreign Body Sensation in Eye 120 120
Pain 99 100
Blurred Vision 95 95
Corneal Scar 89 89
Conjunctivitis 77 77
Bacterial Infection 70 70
Eye Infections 70 70
Dry Eye(s) 64 64
Excessive Tear Production 63 63
Discomfort 62 62
Corneal Abrasion 58 58
Eye Injury 51 51
Corneal Infiltrates 49 49
Loss of Vision 44 44
Visual Impairment 42 42
Irritation 41 41
Local Reaction 39 39
Visual Disturbances 38 38
Burning Sensation 35 35
Unspecified Infection 32 33
Inflammation 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Eye Burn 25 25
No Code Available 24 24
Itching Sensation 23 23
Corneal Edema 21 21
Swelling/ Edema 19 19
Insufficient Information 19 19
Hypersensitivity/Allergic reaction 17 17
Swelling 16 16
Fungal Infection 16 16
Headache 15 15
Neovascularization 14 14
Ulcer 14 14
Uveitis 13 13
Unspecified Eye / Vision Problem 13 13
Erythema 13 13
Erosion 12 12
Acanthameba Keratitis 12 12
Discharge 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Iritis 10 10
Purulent Discharge 10 10
Hypopyon 9 9
Scarring 8 8
Increased Sensitivity 8 8
No Known Impact Or Consequence To Patient 7 7
Corneal Clouding/Hazing 7 7
Abscess 6 6
Cellulitis 6 6
Chemosis 6 6
Intraocular Infection 5 5
Increased Sensitivity 5 5
Foreign Body In Patient 5 5
Corneal Stromal Edema 4 4
Endophthalmitis 4 4
Glaucoma 3 3
Rash 3 3
Hypoxia 3 3
Intraocular Pressure Increased 3 3
Viral Infection 3 3
Ulceration 3 3
Fluid Discharge 3 3
Device Embedded In Tissue or Plaque 3 3
Chemical Exposure 2 2
Injury 2 2
Irritability 2 2
Skin Inflammation/ Irritation 2 2
Sexually Transmitted Infection 2 2
Tingling 2 2
Dizziness 2 2
Laceration(s) 2 2
Retinal Degeneration 2 2
Scar Tissue 2 2
Vitreous Floaters 2 2
Corneal Decompensation 2 2
Corneal Pannus 2 2
Edema 2 2
Deposits 1 1
Corneal Perforation 1 1
Anaphylactic Shock 1 1
Cataract, Induced 1 1
Foreign Body Reaction 1 1
Fungus 1 1
Hemorrhage/Bleeding 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Skin Irritation 1 1
Occlusion 1 1
Anaphylactoid 1 1
Thrombosis 1 1
Microcysts, Epithelial 1 1
Halo 1 1
Clouding, Central Corneal 1 1
Contact Dermatitis 1 1
Angioedema 1 1
Corneal Epithelial Microcysts 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Chengdu Ai Qin E-commerce Co., Ltd II Jul-27-2020
2 Clerio Vision II Apr-05-2021
3 Clerio Vision II Jan-08-2021
4 CooperVision Inc. II Jul-27-2021
5 CooperVision, Inc. II Mar-23-2023
6 CooperVision, Inc. II Jan-24-2023
7 Johnson & Johnson Vision Care, Inc. II Jun-16-2021
8 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
-
-