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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
79 59 55 45 28 17

MDR Year MDR Reports MDR Events
2017 215 215
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 525 525
No Apparent Adverse Event 209 209
Insufficient Information 49 49
Patient-Device Incompatibility 21 21
Defective Device 6 6
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Use of Device Problem 3 3
Microbial Contamination of Device 3 3
Device Operates Differently Than Expected 3 3
Device Contamination with Chemical or Other Material 2 2
Defective Component 2 2
Difficult to Remove 2 2
Material Split, Cut or Torn 2 2
Contamination /Decontamination Problem 2 2
Torn Material 2 2
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Contamination 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Material Opacification 1 1
Product Quality Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 367 367
Corneal Ulcer 356 356
Pain 261 261
Bacterial Infection 183 183
Keratitis 177 177
Irritation 164 164
Discomfort 153 153
Conjunctivitis 125 125
Excessive Tear Production 99 99
Foreign Body Sensation in Eye 94 94
Unspecified Infection 93 93
Swelling 92 92
Blurred Vision 83 83
Corneal Scar 81 81
Burning Sensation 77 77
Discharge 77 77
Itching Sensation 70 70
Dry Eye(s) 62 62
Inflammation 57 57
Corneal Infiltrates 57 57
Eye Pain 47 47
Corneal Abrasion 45 45
Eye Injury 35 35
Loss of Vision 34 34
Visual Impairment 31 31
Acanthameba Keratitis 28 28
Corneal Edema 24 24
Visual Disturbances 21 21
Iritis 18 18
Local Reaction 17 17
Intraocular Infection 15 15
Eye Infections 15 15
Neovascularization 14 14
Fungal Infection 12 12
No Code Available 11 11
Erosion 11 11
Abscess 10 10
Headache 10 10
Hypopyon 8 8
Erythema 7 7
Uveitis 6 6
Ulcer 6 6
Skin Inflammation/ Irritation 6 6
Increased Sensitivity 5 5
Corneal Clouding/Hazing 5 5
Hypersensitivity/Allergic reaction 4 4
Scarring 4 4
Swelling/ Edema 4 4
Fluid Discharge 4 4
Eye Burn 3 3
Caustic/Chemical Burns 3 3
Dizziness 3 3
Scar Tissue 3 3
Vitreous Floaters 3 3
Corneal Decompensation 3 3
Corneal Pannus 3 3
Edema 2 2
Purulent Discharge 2 2
Autoimmune Disorder 2 2
Cataract 2 2
Cellulitis 2 2
Foreign Body Reaction 2 2
Hypoxia 2 2
Nausea 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Deformity/ Disfigurement 2 2
Reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
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
Ptosis 1 1
Tics/Tremor 1 1
Corneal Epithelial Microcysts 1 1
Insufficient Information 1 1
Reaction to Medicinal Component of Device 1 1
Regurgitation, Valvular 1 1
Overwear Syndrome 1 1
Vertigo 1 1
Misdiagnosis 1 1
Twitching 1 1
Necrosis Of Flap Tissue 1 1
Sjogren's Syndrome 1 1
Staphylococcus Aureus 1 1
High Blood Pressure/ Hypertension 1 1
Intraocular Pressure Increased 1 1
Fever 1 1
Hyperemia 1 1
Chemosis 1 1
Corneal Perforation 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 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
5 Lens.com II Dec-05-2019
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