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, extended wear
Product CodeLPM
Regulation Number 886.5925
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
43 79 59 55 45 28 40 15 22

MDR Year MDR Reports MDR Events
2016 220 220
2017 215 215
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 118 118
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 788 788
No Apparent Adverse Event 338 338
Insufficient Information 94 94
Patient-Device Incompatibility 28 28
Improper or Incorrect Procedure or Method 12 12
Appropriate Term/Code Not Available 11 11
Use of Device Problem 10 10
Defective Device 9 9
Fitting Problem 6 6
Device Operates Differently Than Expected 6 6
Torn Material 5 5
Microbial Contamination of Device 5 5
Scratched Material 4 4
Difficult to Remove 4 4
Material Split, Cut or Torn 4 4
Product Quality Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Therapeutic or Diagnostic Output Failure 2 2
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Defective Component 2 2
Component Missing 2 2
Device Handling Problem 2 2
Break 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Fogging 1 1
Material Discolored 1 1
Device Packaging Compromised 1 1
Material Opacification 1 1
Out-Of-Box Failure 1 1
Device Unsafe to Use in Environment 1 1
Unexpected Color 1 1
Entrapment of Device 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Failure to Unfold or Unwrap 1 1
Tear, Rip or Hole in Device Packaging 1 1
Nonstandard Device 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Component Falling 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 567 567
Red Eye(s) 546 546
Pain 339 339
Keratitis 269 269
Bacterial Infection 238 238
Discomfort 222 222
Irritation 216 216
Conjunctivitis 184 184
Excessive Tear Production 162 162
Foreign Body Sensation in Eye 160 160
Blurred Vision 159 159
Eye Pain 153 153
Unspecified Infection 140 140
Swelling 124 124
Corneal Scar 124 124
Discharge 112 112
Itching Sensation 112 112
Dry Eye(s) 111 111
Burning Sensation 100 100
Eye Infections 99 99
Corneal Infiltrates 95 95
Corneal Abrasion 94 94
Inflammation 79 79
Eye Injury 59 59
Loss of Vision 59 59
Visual Impairment 47 47
Visual Disturbances 47 47
Corneal Edema 42 42
Acanthameba Keratitis 41 41
Local Reaction 38 38
Iritis 30 30
Fungal Infection 22 22
Intraocular Infection 20 20
Swelling/ Edema 19 19
Neovascularization 18 18
Headache 16 16
Hypopyon 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Corneal Clouding/Hazing 13 13
Abscess 12 12
Erosion 11 11
No Code Available 11 11
Scar Tissue 11 11
Erythema 11 11
Fluid Discharge 10 10
Uveitis 10 10
Hypersensitivity/Allergic reaction 10 10
Ulcer 9 9
Hyperemia 8 8
Increased Sensitivity 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Allied Vision Group Inc II Apr-29-2020
2 CooperVision Inc. II Jan-27-2020
3 CooperVision Inc. III Feb-23-2018
4 CooperVision, Inc. II Mar-01-2023
5 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
6 Lens.com II Dec-05-2019
-
-