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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)
2018 2019 2020 2021 2022 2023
59 55 45 28 40 12

MDR Year MDR Reports MDR Events
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 614 614
No Apparent Adverse Event 72 72
Insufficient Information 42 42
Patient-Device Incompatibility 12 12
Defective Device 9 9
Appropriate Term/Code Not Available 6 6
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Microbial Contamination of Device 4 4
Material Split, Cut or Torn 4 4
Scratched Material 4 4
Product Quality Problem 3 3
Difficult to Remove 2 2
Break 2 2
Component Missing 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fitting Problem 1 1
Degraded 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Material Opacification 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Unfold or Unwrap 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 366 366
Red Eye(s) 316 316
Pain 184 184
Keratitis 156 156
Bacterial Infection 138 138
Foreign Body Sensation in Eye 116 116
Corneal Scar 107 107
Eye Pain 106 106
Discomfort 99 99
Conjunctivitis 96 96
Excessive Tear Production 94 94
Irritation 93 93
Blurred Vision 81 81
Swelling 66 66
Unspecified Infection 66 66
Eye Infections 60 60
Burning Sensation 57 57
Itching Sensation 54 54
Discharge 52 52
Dry Eye(s) 52 52
Corneal Infiltrates 49 49
Visual Disturbances 40 40
Corneal Abrasion 40 40
Eye Injury 39 39
Inflammation 37 37
Visual Impairment 31 31
Local Reaction 29 29
Acanthameba Keratitis 28 28
Loss of Vision 27 27
Corneal Edema 23 23
Iritis 15 15
Neovascularization 12 12
Headache 12 12
Intraocular Infection 11 11
Fungal Infection 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Hypopyon 9 9
Abscess 9 9
Erosion 8 8
Corneal Clouding/Hazing 8 8
Uveitis 8 8
No Code Available 8 8
Swelling/ Edema 8 8
Insufficient Information 6 6
Skin Inflammation/ Irritation 6 6
Fluid Discharge 6 6
Unspecified Eye / Vision Problem 4 4
Ulcer 4 4
Erythema 4 4
Foreign Body Reaction 3 3
Hypersensitivity/Allergic reaction 3 3
Corneal Pannus 3 3
Corneal Decompensation 3 3
Chemosis 3 3
Purulent Discharge 3 3
Dizziness 3 3
Nausea 3 3
Scar Tissue 3 3
Scarring 3 3
Eye Burn 3 3
Caustic/Chemical Burns 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Ptosis 2 2
Increased Sensitivity 2 2
Injury 2 2
Deformity/ Disfigurement 2 2
Reaction 2 2
Autoimmune Disorder 2 2
Cataract 2 2
Cellulitis 2 2
Hypoxia 2 2
Hyperemia 2 2
Vitreous Floaters 2 2
Granuloma 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Hyphema 1 1
Abrasion 1 1
Corneal Perforation 1 1
Overwear Syndrome 1 1
Twitching 1 1
Vertigo 1 1
Sjogren's Syndrome 1 1
Intraocular Pressure Increased 1 1
Abdominal Cramps 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Tics/Tremor 1 1
Corneal Epithelial Microcysts 1 1
Reaction to Medicinal Component of Device 1 1

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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