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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 5

MDR Year MDR Reports MDR Events
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 571 571
No Apparent Adverse Event 71 71
Insufficient Information 36 36
Patient-Device Incompatibility 11 11
Defective Device 8 8
Appropriate Term/Code Not Available 6 6
Improper or Incorrect Procedure or Method 5 5
Use of Device Problem 3 3
Microbial Contamination of Device 3 3
Component Missing 2 2
Contamination /Decontamination Problem 2 2
Product Quality Problem 2 2
Break 2 2
Material Split, Cut or Torn 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 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
Fitting Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 336 336
Red Eye(s) 298 298
Pain 184 184
Keratitis 153 153
Bacterial Infection 135 135
Foreign Body Sensation in Eye 106 106
Discomfort 99 99
Corneal Scar 99 99
Irritation 93 93
Conjunctivitis 90 90
Excessive Tear Production 89 89
Eye Pain 76 76
Blurred Vision 74 74
Unspecified Infection 66 66
Swelling 66 66
Burning Sensation 55 55
Itching Sensation 53 53
Discharge 52 52
Dry Eye(s) 46 46
Eye Infections 44 44
Corneal Infiltrates 44 44
Visual Disturbances 37 37
Inflammation 36 36
Corneal Abrasion 36 36
Eye Injury 31 31
Visual Impairment 28 28
Loss of Vision 27 27
Local Reaction 26 26
Acanthameba Keratitis 24 24
Corneal Edema 20 20
Iritis 15 15
Headache 12 12
Intraocular Infection 11 11
Neovascularization 11 11
Hypopyon 9 9
Abscess 9 9
Fungal Infection 9 9
Uveitis 8 8
Erosion 8 8
Corneal Clouding/Hazing 8 8
No Code Available 8 8
Swelling/ Edema 7 7
Skin Inflammation/ Irritation 6 6
Fluid Discharge 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Erythema 4 4
Ulcer 4 4
Caustic/Chemical Burns 3 3
Scar Tissue 3 3
Eye Burn 3 3
Foreign Body Reaction 3 3
Nausea 3 3
Corneal Decompensation 3 3
Corneal Pannus 3 3
Insufficient Information 3 3
Purulent Discharge 3 3
Scarring 3 3
Dizziness 3 3
Hypersensitivity/Allergic reaction 3 3
Ptosis 2 2
Hypoxia 2 2
Injury 2 2
Increased Sensitivity 2 2
Cellulitis 2 2
Hyperemia 2 2
Vitreous Floaters 2 2
Autoimmune Disorder 2 2
Reaction 2 2
Deformity/ Disfigurement 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Corneal Perforation 1 1
No Known Impact Or Consequence To Patient 1 1
Cataract 1 1
Abrasion 1 1
Vertigo 1 1
Overwear Syndrome 1 1
Corneal Epithelial Microcysts 1 1
Reaction to Medicinal Component of Device 1 1
Foreign Body In Patient 1 1
Twitching 1 1
Tics/Tremor 1 1
Fever 1 1
Device Embedded In Tissue or Plaque 1 1
Granuloma 1 1
Hyphema 1 1
Intraocular Pressure Increased 1 1
Hemorrhage/Bleeding 1 1
Chemosis 1 1
Sjogren's Syndrome 1 1
Abdominal Cramps 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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