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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)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
26 35 43 79 59 55 45 28 40 15 22

MDR Year MDR Reports MDR Events
2014 110 110
2015 143 143
2016 220 220
2017 215 215
2018 195 195
2019 189 189
2020 107 107
2021 103 103
2022 83 83
2023 118 118
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 876 876
No Apparent Adverse Event 406 406
Insufficient Information 144 144
Patient-Device Incompatibility 29 29
Improper or Incorrect Procedure or Method 21 21
Device Operates Differently Than Expected 17 17
Torn Material 13 13
Appropriate Term/Code Not Available 13 13
Use of Device Problem 12 12
Defective Device 11 11
Difficult to Remove 7 7
Scratched Material 6 6
Fitting Problem 6 6
Microbial Contamination of Device 5 5
Contamination 4 4
Material Split, Cut or Torn 4 4
Device Contamination with Chemical or Other Material 4 4
Break 3 3
Material Integrity Problem 3 3
Product Quality Problem 3 3
Defective Component 2 2
Contamination /Decontamination Problem 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Split 2 2
Component Missing 2 2
Sticking 2 2
Inadequacy of Device Shape and/or Size 2 2
Nonstandard Device 1 1
Unexpected Therapeutic Results 1 1
Optical Discoloration 1 1
Peeled/Delaminated 1 1
Device Markings/Labelling Problem 1 1
Entrapment of Device 1 1
Material Opacification 1 1
Failure to Unfold or Unwrap 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Labelling, Instructions for Use or Training Problem 1 1
Missing Value Reason 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Out-Of-Box Failure 1 1
Positioning Problem 1 1
Device Packaging Compromised 1 1
Material Discolored 1 1
Shelf Life Exceeded 1 1
Degraded 1 1
Fogging 1 1
Component Falling 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 688 688
Red Eye(s) 617 617
Pain 427 427
Keratitis 313 313
Bacterial Infection 262 262
Discomfort 255 255
Irritation 248 248
Unspecified Infection 199 199
Conjunctivitis 199 199
Excessive Tear Production 178 178
Blurred Vision 175 175
Foreign Body Sensation in Eye 168 168
Eye Pain 153 153
Swelling 143 143
Corneal Scar 143 143
Itching Sensation 128 128
Discharge 126 126
Burning Sensation 118 118
Corneal Abrasion 118 118
Dry Eye(s) 118 118
Corneal Infiltrates 115 115
Eye Infections 99 99
Inflammation 86 86
Loss of Vision 83 83
Eye Injury 68 68
Visual Impairment 55 55
Visual Disturbances 51 51
Corneal Edema 49 49
Acanthameba Keratitis 41 41
Iritis 39 39
Local Reaction 38 38
Fungal Infection 26 26
Neovascularization 25 25
Intraocular Infection 23 23
No Code Available 20 20
Swelling/ Edema 19 19
Hypopyon 19 19
Headache 17 17
Corneal Clouding/Hazing 17 17
Scar Tissue 16 16
Abscess 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Hyperemia 14 14
Erosion 14 14
Erythema 13 13
Ulcer 12 12
Uveitis 12 12
Fluid Discharge 12 12
Hypersensitivity/Allergic reaction 11 11
Complaint, Ill-Defined 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Allied Vision Group Inc II Apr-29-2020
2 Cooper Vision Caribbean Corp. II Dec-15-2014
3 CooperVision Inc. II Jan-27-2020
4 CooperVision Inc. III Feb-23-2018
5 CooperVision, Inc. II Mar-01-2023
6 Intertrade Imports Inc. II Jan-12-2015
7 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
8 Lens.com II Dec-05-2019
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