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
  1.  K182782  DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TO ...
  2.  K190045  DAILIES Colors, DAILIES Colors Toric, DAILIES Colo ...
  3.  K222500  AIR OPTIX COLORS
  4.  K230785  Precision1, Precision1 for Astigmatism
  5.  K232921  DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TO ...
  6.  K233856  Precision1; Precision1 for Astigmatism; TOTAL30; T ...
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
  1.  K182782  DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TO ...
  2.  K190045  DAILIES Colors, DAILIES Colors Toric, DAILIES Colo ...
  3.  K222500  AIR OPTIX COLORS
  4.  K230785  Precision1, Precision1 for Astigmatism
  5.  K232921  DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TO ...
  6.  K233856  Precision1; Precision1 for Astigmatism; TOTAL30; T ...
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 4
PLEXUS OPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 520 520
Patient-Device Incompatibility 39 39
Improper or Incorrect Procedure or Method 38 38
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
Fitting Problem 10 10
Difficult to Remove 10 10
Appropriate Term/Code Not Available 9 9
Inadequacy of Device Shape and/or Size 7 7
Defective Device 7 7
Nonstandard Device 6 6
Patient Device Interaction Problem 6 6
Device Markings/Labelling Problem 4 4
Contamination /Decontamination Problem 4 4
Defective Component 4 4
Particulates 3 3
Therapeutic or Diagnostic Output Failure 3 3
Entrapment of Device 3 3
Material Opacification 3 3
Device Handling Problem 3 3
Material Deformation 3 3
Physical Resistance/Sticking 2 2
Off-Label Use 2 2
Fungus in Device Environment 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Sharp Edges 2 2
Labelling, Instructions for Use or Training Problem 2 2
Component Missing 2 2
Expiration Date Error 2 2
Material Disintegration 2 2
Material Twisted/Bent 2 2
Material Discolored 1 1
Migration 1 1
Material Integrity Problem 1 1
Contamination 1 1
Material Invagination 1 1
No Apparent Adverse Event 1 1
Material Puncture/Hole 1 1
Packaging Problem 1 1
Crack 1 1
Naturally Worn 1 1
Difficult to Open or Remove Packaging Material 1 1
Positioning Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Damaged Prior to Use 1 1
Expulsion 1 1
Material Too Rigid or Stiff 1 1
Difficult to Fold, Unfold or Collapse 1 1
Dent in Material 1 1
Wrong Label 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 314 314
Red Eye(s) 197 197
Eye Pain 156 156
Keratitis 119 119
Foreign Body Sensation in Eye 106 106
Pain 98 99
Corneal Scar 84 84
Blurred Vision 81 81
Conjunctivitis 68 68
Bacterial Infection 63 63
Dry Eye(s) 62 62
Eye Infections 60 60
Excessive Tear Production 59 59
Discomfort 57 57
Corneal Abrasion 52 52
Eye Injury 49 49
Corneal Infiltrates 45 45
Visual Impairment 41 41
Irritation 41 41
Loss of Vision 41 41
Visual Disturbances 36 36
Local Reaction 35 35
Burning Sensation 34 34
Unspecified Infection 32 33
Inflammation 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
No Code Available 24 24
Itching Sensation 22 22
Corneal Edema 21 21
Eye Burn 19 19
Swelling 16 16
Swelling/ Edema 15 15
Fungal Infection 14 14
Neovascularization 14 14
Ulcer 14 14
Erythema 13 13
Headache 13 13
Uveitis 13 13
Unspecified Eye / Vision Problem 12 12
Discharge 12 12
Hypersensitivity/Allergic reaction 11 11
Insufficient Information 11 11
Iritis 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Acanthameba Keratitis 10 10
Hypopyon 9 9
Increased Sensitivity 8 8
Scarring 8 8
Purulent Discharge 8 8
Erosion 8 8
Corneal Clouding/Hazing 7 7
No Known Impact Or Consequence To Patient 7 7
Cellulitis 6 6
Abscess 6 6
Intraocular Infection 5 5
Increased Sensitivity 5 5
Chemosis 4 4
Endophthalmitis 4 4
Corneal Stromal Edema 4 4
Foreign Body In Patient 3 3
Hypoxia 3 3
Intraocular Pressure Increased 3 3
Ulceration 3 3
Glaucoma 3 3
Viral Infection 3 3
Device Embedded In Tissue or Plaque 3 3
Dizziness 2 2
Injury 2 2
Sexually Transmitted Infection 2 2
Rash 2 2
Corneal Decompensation 2 2
Fluid Discharge 2 2
Tingling 2 2
Edema 2 2
Skin Inflammation/ Irritation 2 2
Irritability 2 2
Chemical Exposure 2 2
Retinal Degeneration 2 2
Scar Tissue 2 2
Laceration(s) 2 2
Halo 1 1
Clouding, Central Corneal 1 1
Tissue Breakdown 1 1
Complaint, Ill-Defined 1 1
Corneal Perforation 1 1
Cataract, Induced 1 1
Coma 1 1
Sleep Dysfunction 1 1
Contact Dermatitis 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Foreign Body Reaction 1 1
Thrombosis 1 1
Microcysts, Epithelial 1 1
Corneal Epithelial Microcysts 1 1
Vitreous Floaters 1 1
Anaphylactic Shock 1 1
Hemorrhage/Bleeding 1 1
Low Oxygen Saturation 1 1
Occlusion 1 1
Anaphylactoid 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
-
-