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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 36

MDR Year MDR Reports MDR Events
2017 215 215
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 564 564
No Apparent Adverse Event 209 209
Insufficient Information 49 49
Patient-Device Incompatibility 21 21
Defective Device 7 7
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Device Operates Differently Than Expected 3 3
Microbial Contamination of Device 3 3
Use of Device Problem 3 3
Contamination /Decontamination Problem 2 2
Component Missing 2 2
Defective Component 2 2
Difficult to Remove 2 2
Device Contamination with Chemical or Other Material 2 2
Material Split, Cut or Torn 2 2
Scratched Material 2 2
Torn Material 2 2
Therapeutic or Diagnostic Output Failure 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Separation 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
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 385 385
Red Eye(s) 380 380
Pain 261 261
Bacterial Infection 187 187
Keratitis 185 185
Irritation 164 164
Discomfort 153 153
Conjunctivitis 127 127
Foreign Body Sensation in Eye 107 107
Excessive Tear Production 106 106
Unspecified Infection 93 93
Swelling 92 92
Corneal Scar 90 90
Blurred Vision 88 88
Burning Sensation 77 77
Discharge 77 77
Itching Sensation 74 74
Dry Eye(s) 64 64
Eye Pain 63 63
Corneal Infiltrates 60 60
Inflammation 58 58
Corneal Abrasion 48 48
Eye Injury 36 36
Loss of Vision 36 36
Visual Impairment 33 33
Visual Disturbances 28 28
Acanthameba Keratitis 28 28
Corneal Edema 24 24
Eye Infections 22 22
Iritis 19 19
Local Reaction 19 19
Intraocular Infection 15 15
Neovascularization 14 14
Headache 12 12
Fungal Infection 12 12
No Code Available 11 11
Erosion 11 11
Abscess 10 10
Hypopyon 9 9
Uveitis 8 8
Erythema 7 7
Corneal Clouding/Hazing 7 7
Ulcer 6 6
Skin Inflammation/ Irritation 6 6
Increased Sensitivity 5 5
Scarring 4 4
Hypersensitivity/Allergic reaction 4 4
Purulent Discharge 4 4
Swelling/ Edema 4 4
Fluid Discharge 4 4
Eye Burn 3 3
Caustic/Chemical Burns 3 3
Corneal Pannus 3 3
Corneal Decompensation 3 3
Vitreous Floaters 3 3
Dizziness 3 3
Scar Tissue 3 3
Nausea 2 2
Complaint, Ill-Defined 2 2
Foreign Body Reaction 2 2
Hyperemia 2 2
Hypoxia 2 2
Autoimmune Disorder 2 2
Cataract 2 2
Cellulitis 2 2
Edema 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Injury 2 2
Deformity/ Disfigurement 2 2
Reaction 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
Reaction to Medicinal Component of Device 1 1
Corneal Perforation 1 1
Chemosis 1 1
High Blood Pressure/ Hypertension 1 1
Hyphema 1 1
Intraocular Pressure Increased 1 1
Fever 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

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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