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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 16

MDR Year MDR Reports MDR Events
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 118 118
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 574 574
Insufficient Information 46 46
Use of Device Problem 7 7
Defective Device 7 7
Improper or Incorrect Procedure or Method 6 6
Patient-Device Incompatibility 5 5
Scratched Material 4 4
No Apparent Adverse Event 4 4
Material Split, Cut or Torn 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
Patient Device Interaction Problem 1 1
Unexpected Color 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
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 322 322
Red Eye(s) 265 265
Eye Pain 142 142
Keratitis 140 140
Foreign Body Sensation in Eye 110 110
Pain 108 108
Bacterial Infection 107 107
Eye Infections 91 91
Conjunctivitis 86 86
Corneal Scar 86 86
Excessive Tear Production 80 80
Blurred Vision 77 77
Discomfort 76 76
Irritation 62 62
Corneal Infiltrates 48 48
Dry Eye(s) 48 48
Unspecified Infection 42 42
Burning Sensation 42 42
Itching Sensation 42 42
Visual Disturbances 41 41
Swelling 37 37
Corneal Abrasion 37 37
Local Reaction 36 36
Eye Injury 35 35
Inflammation 34 34
Discharge 31 31
Visual Impairment 27 27
Corneal Edema 27 27
Loss of Vision 18 18
Swelling/ Edema 17 17
Acanthameba Keratitis 16 16
Neovascularization 11 11
Hypopyon 11 11
Iritis 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Fungal Infection 10 10
Headache 10 10
Corneal Clouding/Hazing 9 9
Hyperemia 7 7
Hypersensitivity/Allergic reaction 7 7
Abscess 7 7
No Code Available 7 7
Fluid Discharge 7 7
Insufficient Information 6 6
Unspecified Eye / Vision Problem 6 6
Skin Inflammation/ Irritation 6 6
Uveitis 6 6
Eye Burn 4 4
Erosion 4 4
Foreign Body Reaction 4 4
Corneal Stromal Edema 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Caustic/Chemical Burns 3 3
Erythema 3 3
Intraocular Infection 3 3
Corneal Pannus 3 3
Corneal Decompensation 3 3
Cellulitis 3 3
Chemosis 3 3
Ulcer 3 3
Nausea 3 3
Increased Sensitivity 2 2
Scar Tissue 2 2
Dizziness 2 2
Cataract 2 2
Purulent Discharge 2 2
Intraocular Pressure Increased 2 2
Vitreous Floaters 2 2
Ptosis 2 2
Reaction 2 2
Tics/Tremor 1 1
Corneal Epithelial Microcysts 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
Granuloma 1 1
Hyphema 1 1
Hemorrhage/Bleeding 1 1
Microcystic Edema 1 1
Deposits 1 1
Abrasion 1 1
Overwear Syndrome 1 1
Twitching 1 1
Viral Infection 1 1
Abdominal Cramps 1 1
Deformity/ Disfigurement 1 1
Scarring 1 1
Nerve Damage 1 1
Hypoxia 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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