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TPLC
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show TPLC since
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2024
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Device
lens, contact, (disposable)
Product Code
MVN
Regulation Number
886.5925
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
18
18
2017
23
23
2018
32
32
2019
34
34
2020
32
32
2021
24
24
2022
18
18
2023
24
24
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
132
132
Insufficient Information
24
24
Defective Device
13
13
Improper or Incorrect Procedure or Method
12
12
Patient-Device Incompatibility
12
12
Material Split, Cut or Torn
7
7
Product Quality Problem
6
6
Break
4
4
Entrapment of Device
3
3
Material Fragmentation
2
2
Material Rupture
2
2
Use of Device Problem
2
2
Expiration Date Error
2
2
Torn Material
2
2
Device Contamination with Chemical or Other Material
2
2
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Twisted/Bent
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Dislodged or Dislocated
1
1
Expulsion
1
1
Packaging Problem
1
1
Device Or Device Fragments Location Unknown
1
1
Component Falling
1
1
Contamination
1
1
Fitting Problem
1
1
Component Missing
1
1
Material Separation
1
1
Sticking
1
1
Particulates
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
65
65
Pain
56
56
Red Eye(s)
52
52
Eye Injury
27
27
Keratitis
25
25
Eye Pain
25
25
Unspecified Infection
24
24
Blurred Vision
23
23
Eye Infections
22
22
Discomfort
22
22
Corneal Abrasion
21
21
Corneal Edema
19
19
Corneal Scar
18
18
Irritation
18
18
Visual Impairment
16
16
Loss of Vision
16
16
Corneal Infiltrates
16
16
Conjunctivitis
14
14
Excessive Tear Production
11
11
Acanthameba Keratitis
10
10
Inflammation
10
10
Discharge
9
9
Burning Sensation
9
9
Neovascularization
8
8
Foreign Body Sensation in Eye
8
8
Dry Eye(s)
7
7
Iritis
7
7
Ulcer
7
7
Headache
6
6
Bacterial Infection
6
6
Erosion
5
5
Swelling
5
5
Fungal Infection
5
5
Visual Disturbances
4
4
Itching Sensation
4
4
Purulent Discharge
3
3
Corneal Stromal Edema
3
3
No Code Available
3
3
Skin Inflammation/ Irritation
3
3
Swelling/ Edema
2
2
Intraocular Pressure Decreased
2
2
Eye Burn
2
2
Device Embedded In Tissue or Plaque
2
2
Vomiting
2
2
Halo
2
2
Reaction
2
2
Corneal Clouding/Hazing
2
2
Nausea
2
2
Hemorrhage/Bleeding
2
2
Hyphema
2
2
Hypopyon
2
2
Hyperemia
1
1
Hypersensitivity/Allergic reaction
1
1
Staphylococcus Aureus
1
1
Laceration(s)
1
1
Erythema
1
1
Edema
1
1
Syncope
1
1
Abrasion
1
1
Abscess
1
1
Anoxia
1
1
Collapse
1
1
Coma
1
1
Loss of consciousness
1
1
Uveitis
1
1
Convulsion, Clonic
1
1
Injury
1
1
Meningitis
1
1
Fluid Discharge
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Unspecified Eye / Vision Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperVision Inc.
III
Apr-25-2018
2
Johnson & Johnson Vision Care, Inc.
II
Apr-17-2020
3
Johnson & Johnson Vision Care, Inc.
II
Mar-27-2018
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