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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)
2019 2020 2021 2022 2023 2024
55 45 28 40 15 5

MDR Year MDR Reports MDR Events
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 118 118
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 545 545
Insufficient Information 41 41
Use of Device Problem 7 7
Defective Device 7 7
Patient-Device Incompatibility 5 5
Improper or Incorrect Procedure or Method 5 5
Material Split, Cut or Torn 4 4
Scratched Material 4 4
No Apparent Adverse Event 4 4
Appropriate Term/Code Not Available 3 3
Product Quality Problem 3 3
Difficult to Remove 2 2
Break 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Degraded 1 1
Material Discolored 1 1
Nonstandard Device 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Unfold or Unwrap 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 307 307
Red Eye(s) 251 251
Keratitis 130 130
Eye Pain 125 125
Pain 107 107
Bacterial Infection 104 104
Foreign Body Sensation in Eye 104 104
Corneal Scar 85 85
Conjunctivitis 80 80
Excessive Tear Production 78 78
Eye Infections 78 78
Discomfort 73 73
Blurred Vision 73 73
Irritation 62 62
Corneal Infiltrates 47 47
Dry Eye(s) 44 44
Unspecified Infection 42 42
Burning Sensation 42 42
Visual Disturbances 41 41
Itching Sensation 37 37
Swelling 37 37
Corneal Abrasion 37 37
Eye Injury 34 34
Inflammation 33 33
Local Reaction 31 31
Discharge 31 31
Visual Impairment 27 27
Corneal Edema 26 26
Loss of Vision 18 18
Acanthameba Keratitis 15 15
Swelling/ Edema 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Iritis 11 11
Neovascularization 11 11
Headache 10 10
Corneal Clouding/Hazing 9 9
Hypopyon 9 9
Fungal Infection 9 9
Abscess 7 7
No Code Available 7 7
Insufficient Information 6 6
Unspecified Eye / Vision Problem 6 6
Skin Inflammation/ Irritation 6 6
Uveitis 6 6
Fluid Discharge 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Eye Burn 4 4
Erosion 4 4
Hypersensitivity/Allergic reaction 4 4
Foreign Body Reaction 4 4
Hyperemia 3 3
Intraocular Infection 3 3
Chemosis 3 3
Corneal Pannus 3 3
Corneal Decompensation 3 3
Corneal Stromal Edema 3 3
Erythema 3 3
Ulcer 3 3
Nausea 3 3
Caustic/Chemical Burns 3 3
Ptosis 2 2
Scar Tissue 2 2
Reaction 2 2
Dizziness 2 2
Increased Sensitivity 2 2
Cataract 2 2
Cellulitis 2 2
Intraocular Pressure Increased 2 2
Purulent Discharge 2 2
Vitreous Floaters 2 2
Hemorrhage/Bleeding 1 1
Granuloma 1 1
Hyphema 1 1
Abrasion 1 1
Deposits 1 1
Twitching 1 1
Overwear Syndrome 1 1
Abdominal Cramps 1 1
Deformity/ Disfigurement 1 1
Viral Infection 1 1
Scarring 1 1
Hypoxia 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Reaction to Medicinal Component of Device 1 1
Tics/Tremor 1 1
Corneal Epithelial Microcysts 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. II Mar-01-2023
4 Lens.com II Dec-05-2019
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