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TPLC
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show TPLC since
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2019
2020
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2024
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Device
lenses, soft contact, extended wear
Product Code
LPM
Regulation Number
886.5925
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
55
45
28
40
15
2
MDR Year
MDR Reports
MDR Events
2019
189
189
2020
107
107
2021
103
103
2022
83
83
2023
118
118
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
537
537
Insufficient Information
38
38
Use of Device Problem
7
7
Defective Device
7
7
Patient-Device Incompatibility
5
5
Improper or Incorrect Procedure or Method
4
4
Material Split, Cut or Torn
4
4
Scratched Material
4
4
No Apparent Adverse Event
4
4
Appropriate Term/Code Not Available
3
3
Product Quality Problem
3
3
Difficult to Remove
2
2
Break
2
2
Component Missing
2
2
Therapeutic or Diagnostic Output Failure
1
1
Device Handling Problem
1
1
Degraded
1
1
Material Discolored
1
1
Nonstandard Device
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Failure to Unfold or Unwrap
1
1
Fitting Problem
1
1
Microbial Contamination of Device
1
1
Contamination /Decontamination Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
302
302
Red Eye(s)
248
248
Keratitis
129
129
Eye Pain
121
121
Pain
107
107
Bacterial Infection
104
104
Foreign Body Sensation in Eye
103
103
Corneal Scar
84
84
Conjunctivitis
80
80
Excessive Tear Production
75
75
Discomfort
73
73
Eye Infections
71
71
Blurred Vision
70
70
Irritation
62
62
Corneal Infiltrates
47
47
Dry Eye(s)
43
43
Unspecified Infection
42
42
Burning Sensation
41
41
Visual Disturbances
40
40
Swelling
37
37
Itching Sensation
36
36
Corneal Abrasion
35
35
Inflammation
33
33
Eye Injury
31
31
Discharge
31
31
Local Reaction
30
30
Visual Impairment
26
26
Corneal Edema
26
26
Loss of Vision
17
17
Acanthameba Keratitis
15
15
Iritis
11
11
Neovascularization
11
11
Headache
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Swelling/ Edema
9
9
Fungal Infection
9
9
Corneal Clouding/Hazing
8
8
Hypopyon
8
8
Abscess
7
7
No Code Available
7
7
Unspecified Eye / Vision Problem
6
6
Skin Inflammation/ Irritation
6
6
Insufficient Information
6
6
Uveitis
6
6
Fluid Discharge
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Erosion
4
4
Foreign Body Reaction
4
4
Hyperemia
3
3
Hypersensitivity/Allergic reaction
3
3
Intraocular Infection
3
3
Chemosis
3
3
Corneal Pannus
3
3
Corneal Decompensation
3
3
Corneal Stromal Edema
3
3
Erythema
3
3
Nausea
3
3
Eye Burn
3
3
Caustic/Chemical Burns
3
3
Ulcer
3
3
Reaction
2
2
Ptosis
2
2
Dizziness
2
2
Scar Tissue
2
2
Increased Sensitivity
2
2
Purulent Discharge
2
2
Cataract
2
2
Cellulitis
2
2
Vitreous Floaters
2
2
Granuloma
1
1
Hemorrhage/Bleeding
1
1
Intraocular Pressure Increased
1
1
Hyphema
1
1
Hypoxia
1
1
Abrasion
1
1
Scarring
1
1
Twitching
1
1
Overwear Syndrome
1
1
Viral Infection
1
1
Abdominal Cramps
1
1
Deformity/ Disfigurement
1
1
Foreign Body In Patient
1
1
No Known Impact Or Consequence To Patient
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.
II
Mar-01-2023
4
Lens.com
II
Dec-05-2019
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