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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
Regulation Description Soft (hydrophilic) contact lens.
Product CodeLPM
Regulation Number 886.5925
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
35 43 79 59 55 35

MDR Year MDR Reports MDR Events
2015 143 143
2016 220 220
2017 215 215
2018 194 194
2019 189 189
2020 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Contact Lens 717 717
Adverse Event Without Identified Device or Use Problem 459 459
No Apparent Adverse Event 398 398
Insufficient Information 73 73
Patient-Device Incompatibility 26 26
Improper or Incorrect Procedure or Method 13 13
Appropriate Term/Code Not Available 12 12
Device Operates Differently Than Expected 10 10
Torn Material 8 8
Defective Device 5 5
Microbial Contamination of Device 4 4
Lenses 3 3
Difficult to Remove 3 3
Use of Device Problem 3 3
Scratched Material 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Inadequacy of Device Shape and/or Size 2 2
Sticking 2 2
Fitting Problem 2 2
Defective Component 2 2
Therapeutic or Diagnostic Output Failure 2 2
Out-Of-Box Failure 1 1
Device Packaging Compromised 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Optical Discoloration 1 1
IOL (Intraocular Lens) Implant 1 1
Shelf Life Exceeded 1 1
Break 1 1
Fogging 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Opacification 1 1
Device Handling Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Device Unsafe to Use in Environment 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Contamination 1 1
Entrapment of Device 1 1
Peeled/Delaminated 1 1
Unexpected Therapeutic Results 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 447 447
Corneal Ulcer 413 413
Pain 365 365
Irritation 230 230
Discomfort 227 227
Bacterial Infection 204 204
Keratitis 203 203
Unspecified Infection 165 165
Conjunctivitis 151 151
Swelling 132 132
Excessive Tear Production 125 125
Discharge 117 117
Blurred Vision 107 107
Burning Sensation 103 103
Itching Sensation 95 95
Dry Eye(s) 80 80
Corneal Abrasion 75 75
Inflammation 74 74
Corneal Infiltrates 70 70
Foreign Body Sensation in Eye 67 67
Corneal Scar 67 67
Loss of Vision 66 66
Eye Injury 34 34
Visual Impairment 32 32
Iritis 30 30
Corneal Edema 29 29
Acanthameba Keratitis 27 27
Intraocular Infection 20 20
Scar Tissue 16 16
Fungal Infection 14 14
Neovascularization 13 13
No Code Available 13 13
Headache 11 11
Hypopyon 11 11
Ulcer 11 11
Corneal Clouding/Hazing 10 10
Erosion 9 9
Abscess 9 9
Erythema 8 8
Scarring 8 8
Reaction 7 7
Increased Sensitivity 7 7
Visual Disturbances 5 5
Corneal Decompensation 5 5
Fluid Discharge 5 5
No Known Impact Or Consequence To Patient 5 5
Complaint, Ill-Defined 5 5
Nausea 5 5
Uveitis 5 5
Edema 5 5
Purulent Discharge 4 4
Injury 4 4
Corneal Pannus 4 4
Vitreous Floaters 3 3
Hypersensitivity/Allergic reaction 3 3
Cataract 3 3
Caustic/Chemical Burns 3 3
Dizziness 3 3
Laceration(s) 2 2
Endophthalmitis 2 2
Foreign Body Reaction 2 2
Hyperemia 2 2
Irritability 2 2
Ptosis 2 2
Abdominal Cramps 2 2
Vitrectomy 2 2
Viral Infection 2 2
Deformity/ Disfigurement 2 2
Herpes 2 2
Autoimmune Disorder 2 2
Abrasion 1 1
Burn(s) 1 1
Fever 1 1
Corneal Perforation 1 1
Corneal Stromal Edema 1 1
Neonatal Hearing Loss 1 1
Staphylococcus Aureus 1 1
High Blood Pressure/ Hypertension 1 1
Misdiagnosis 1 1
Sjogren's Syndrome 1 1
Skin Discoloration 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Vertigo 1 1
Palpitations 1 1
Regurgitation, Valvular 1 1
Lethargy 1 1
Eye Infections 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Eye Burn 1 1
Hypoxia 1 1
Chest Pain 1 1
Necrosis Of Flap Tissue 1 1
Tissue Damage 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 Intertrade Imports Inc. II Jan-12-2015
5 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
6 Lens.com II Dec-05-2019
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