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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lenses, soft contact, extended wear
Product CodeLPM
Regulation Number 886.5925
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022 2023 2024
79 59 55 45 28 40 15 23

MDR Year MDR Reports MDR Events
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 744 744
No Apparent Adverse Event 213 213
Insufficient Information 71 71
Patient-Device Incompatibility 22 22
Use of Device Problem 10 10
Defective Device 9 9
Improper or Incorrect Procedure or Method 8 8
Appropriate Term/Code Not Available 6 6
Microbial Contamination of Device 4 4
Scratched Material 4 4
Difficult to Remove 4 4
Fitting Problem 4 4
Material Split, Cut or Torn 4 4
Product Quality Problem 3 3
Device Operates Differently Than Expected 3 3
Break 2 2
Defective Component 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Torn Material 2 2
Component Missing 2 2
Material Opacification 1 1
Entrapment of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Contamination 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Unfold or Unwrap 1 1
Sticking 1 1
Material Separation 1 1
Nonstandard Device 1 1
Device Handling Problem 1 1
Unexpected Color 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 488 488
Red Eye(s) 455 455
Pain 263 263
Keratitis 234 234
Bacterial Infection 198 198
Irritation 164 164
Discomfort 161 161
Eye Pain 153 153
Conjunctivitis 149 149
Foreign Body Sensation in Eye 146 146
Blurred Vision 129 129
Excessive Tear Production 128 128
Corneal Scar 120 120
Eye Infections 99 99
Unspecified Infection 93 93
Swelling 92 92
Itching Sensation 89 89
Dry Eye(s) 87 87
Burning Sensation 85 85
Corneal Infiltrates 84 84
Discharge 77 77
Corneal Abrasion 70 70
Inflammation 63 63
Eye Injury 54 54
Visual Disturbances 46 46
Loss of Vision 42 42
Acanthameba Keratitis 39 39
Visual Impairment 39 39
Local Reaction 38 38
Corneal Edema 36 36
Fungal Infection 20 20
Swelling/ Edema 19 19
Iritis 19 19
Neovascularization 17 17
Intraocular Infection 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Headache 13 13
Hypopyon 13 13
Erosion 11 11
No Code Available 11 11
Abscess 10 10
Hypersensitivity/Allergic reaction 10 10
Corneal Clouding/Hazing 10 10
Erythema 9 9
Hyperemia 8 8
Fluid Discharge 8 8
Uveitis 8 8
Ulcer 7 7
Unspecified Eye / Vision Problem 7 7
Skin Inflammation/ Irritation 6 6

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
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