Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
3
MDR Year
MDR Reports
MDR Events
2019
189
189
2020
107
107
2021
103
103
2022
83
83
2023
118
118
2024
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
545
545
Insufficient Information
41
41
Defective Device
7
7
Use of Device Problem
7
7
Improper or Incorrect Procedure or Method
5
5
Patient-Device Incompatibility
5
5
Material Split, Cut or Torn
4
4
No Apparent Adverse Event
4
4
Scratched Material
4
4
Appropriate Term/Code Not Available
3
3
Product Quality Problem
3
3
Difficult to Remove
2
2
Component Missing
2
2
Break
2
2
Nonstandard Device
1
1
Failure to Unfold or Unwrap
1
1
Microbial Contamination of Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Fitting Problem
1
1
Material Separation
1
1
Device Handling Problem
1
1
Degraded
1
1
Therapeutic or Diagnostic Output Failure
1
1
Contamination /Decontamination Problem
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
307
307
Red Eye(s)
251
251
Keratitis
130
130
Eye Pain
125
125
Pain
107
107
Bacterial Infection
104
104
Foreign Body Sensation in Eye
104
104
Corneal Scar
85
85
Conjunctivitis
80
80
Excessive Tear Production
78
78
Eye Infections
78
78
Discomfort
73
73
Blurred Vision
73
73
Irritation
62
62
Corneal Infiltrates
47
47
Dry Eye(s)
44
44
Unspecified Infection
42
42
Burning Sensation
42
42
Visual Disturbances
41
41
Itching Sensation
37
37
Swelling
37
37
Corneal Abrasion
37
37
Eye Injury
34
34
Inflammation
33
33
Local Reaction
31
31
Discharge
31
31
Visual Impairment
27
27
Corneal Edema
26
26
Loss of Vision
18
18
Acanthameba Keratitis
15
15
Swelling/ Edema
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Iritis
11
11
Neovascularization
11
11
Headache
10
10
Corneal Clouding/Hazing
9
9
Hypopyon
9
9
Fungal Infection
9
9
Abscess
7
7
No Code Available
7
7
Insufficient Information
6
6
Unspecified Eye / Vision Problem
6
6
Skin Inflammation/ Irritation
6
6
Uveitis
6
6
Fluid Discharge
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Eye Burn
4
4
Erosion
4
4
Hypersensitivity/Allergic reaction
4
4
Foreign Body Reaction
4
4
Hyperemia
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
Ulcer
3
3
Nausea
3
3
Caustic/Chemical Burns
3
3
Ptosis
2
2
Scar Tissue
2
2
Reaction
2
2
Dizziness
2
2
Increased Sensitivity
2
2
Cataract
2
2
Cellulitis
2
2
Intraocular Pressure Increased
2
2
Purulent Discharge
2
2
Vitreous Floaters
2
2
Hemorrhage/Bleeding
1
1
Granuloma
1
1
Hyphema
1
1
Abrasion
1
1
Deposits
1
1
Twitching
1
1
Overwear Syndrome
1
1
Abdominal Cramps
1
1
Deformity/ Disfigurement
1
1
Viral Infection
1
1
Scarring
1
1
Hypoxia
1
1
Foreign Body In Patient
1
1
No Known Impact Or Consequence To Patient
1
1
Reaction to Medicinal Component of Device
1
1
Tics/Tremor
1
1
Corneal Epithelial Microcysts
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
-
-