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TPLC
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show TPLC since
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Device
lenses, soft contact, extended wear
Product Code
LPM
Regulation Number
886.5925
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
59
55
45
28
40
12
MDR Year
MDR Reports
MDR Events
2018
195
195
2019
189
189
2020
107
107
2021
103
103
2022
83
83
2023
91
91
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
614
614
No Apparent Adverse Event
72
72
Insufficient Information
42
42
Patient-Device Incompatibility
12
12
Defective Device
9
9
Appropriate Term/Code Not Available
6
6
Use of Device Problem
5
5
Improper or Incorrect Procedure or Method
5
5
Microbial Contamination of Device
4
4
Material Split, Cut or Torn
4
4
Scratched Material
4
4
Product Quality Problem
3
3
Difficult to Remove
2
2
Break
2
2
Component Missing
2
2
Contamination /Decontamination Problem
2
2
Device Contamination with Chemical or Other Material
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Fitting Problem
1
1
Degraded
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Material Opacification
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Failure to Unfold or Unwrap
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
366
366
Red Eye(s)
316
316
Pain
184
184
Keratitis
156
156
Bacterial Infection
138
138
Foreign Body Sensation in Eye
116
116
Corneal Scar
107
107
Eye Pain
106
106
Discomfort
99
99
Conjunctivitis
96
96
Excessive Tear Production
94
94
Irritation
93
93
Blurred Vision
81
81
Swelling
66
66
Unspecified Infection
66
66
Eye Infections
60
60
Burning Sensation
57
57
Itching Sensation
54
54
Discharge
52
52
Dry Eye(s)
52
52
Corneal Infiltrates
49
49
Visual Disturbances
40
40
Corneal Abrasion
40
40
Eye Injury
39
39
Inflammation
37
37
Visual Impairment
31
31
Local Reaction
29
29
Acanthameba Keratitis
28
28
Loss of Vision
27
27
Corneal Edema
23
23
Iritis
15
15
Neovascularization
12
12
Headache
12
12
Intraocular Infection
11
11
Fungal Infection
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Hypopyon
9
9
Abscess
9
9
Erosion
8
8
Corneal Clouding/Hazing
8
8
Uveitis
8
8
No Code Available
8
8
Swelling/ Edema
8
8
Insufficient Information
6
6
Skin Inflammation/ Irritation
6
6
Fluid Discharge
6
6
Unspecified Eye / Vision Problem
4
4
Ulcer
4
4
Erythema
4
4
Foreign Body Reaction
3
3
Hypersensitivity/Allergic reaction
3
3
Corneal Pannus
3
3
Corneal Decompensation
3
3
Chemosis
3
3
Purulent Discharge
3
3
Dizziness
3
3
Nausea
3
3
Scar Tissue
3
3
Scarring
3
3
Eye Burn
3
3
Caustic/Chemical Burns
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Ptosis
2
2
Increased Sensitivity
2
2
Injury
2
2
Deformity/ Disfigurement
2
2
Reaction
2
2
Autoimmune Disorder
2
2
Cataract
2
2
Cellulitis
2
2
Hypoxia
2
2
Hyperemia
2
2
Vitreous Floaters
2
2
Granuloma
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Hyphema
1
1
Abrasion
1
1
Corneal Perforation
1
1
Overwear Syndrome
1
1
Twitching
1
1
Vertigo
1
1
Sjogren's Syndrome
1
1
Intraocular Pressure Increased
1
1
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
Tics/Tremor
1
1
Corneal Epithelial Microcysts
1
1
Reaction to Medicinal Component of Device
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
CooperVision, Inc.
II
Mar-01-2023
5
Johnson & Johnson Vision Care, Inc.
II
Mar-27-2018
6
Lens.com
II
Dec-05-2019
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