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TPLC
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show TPLC since
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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
2017
23
23
2018
32
32
2019
34
34
2020
32
32
2021
24
24
2022
18
18
2023
24
24
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
123
123
Insufficient Information
20
20
Improper or Incorrect Procedure or Method
11
11
Defective Device
11
11
Patient-Device Incompatibility
11
11
Material Split, Cut or Torn
8
8
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
Device Contamination with Chemical or Other Material
2
2
Torn Material
2
2
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Twisted/Bent
1
1
Packaging Problem
1
1
Fitting Problem
1
1
Component Missing
1
1
Device Dislodged or Dislocated
1
1
Expulsion
1
1
Device Or Device Fragments Location Unknown
1
1
Material Separation
1
1
Sticking
1
1
Particulates
1
1
Contamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
60
60
Pain
51
51
Red Eye(s)
50
50
Eye Pain
26
26
Eye Injury
24
24
Keratitis
23
23
Eye Infections
23
23
Blurred Vision
21
21
Unspecified Infection
21
21
Corneal Abrasion
20
20
Corneal Edema
18
18
Irritation
17
17
Corneal Scar
16
16
Visual Impairment
16
16
Corneal Infiltrates
16
16
Discomfort
16
16
Loss of Vision
14
14
Conjunctivitis
14
14
Excessive Tear Production
12
12
Inflammation
11
11
Acanthameba Keratitis
10
10
Burning Sensation
9
9
Discharge
9
9
Neovascularization
8
8
Foreign Body Sensation in Eye
8
8
Dry Eye(s)
7
7
Ulcer
7
7
Headache
6
6
Bacterial Infection
6
6
Iritis
6
6
Swelling
5
5
Erosion
5
5
Fungal Infection
5
5
Visual Disturbances
4
4
Itching Sensation
4
4
Hyphema
3
3
Purulent Discharge
3
3
Corneal Stromal Edema
3
3
Skin Inflammation/ Irritation
3
3
Swelling/ Edema
2
2
Eye Burn
2
2
Foreign Body In Patient
2
2
Device Embedded In Tissue or Plaque
2
2
Intraocular Pressure Decreased
2
2
Vomiting
2
2
Halo
2
2
Reaction
2
2
Corneal Clouding/Hazing
2
2
Hemorrhage/Bleeding
2
2
Hypopyon
2
2
Nausea
2
2
Laceration(s)
1
1
Uveitis
1
1
Staphylococcus Aureus
1
1
Infiltration into Tissue
1
1
Hyperemia
1
1
Hypersensitivity/Allergic reaction
1
1
Erythema
1
1
Syncope
1
1
Abrasion
1
1
Abscess
1
1
Collapse
1
1
Coma
1
1
Loss of consciousness
1
1
Injury
1
1
Meningitis
1
1
Convulsion, Clonic
1
1
Unspecified Eye / Vision Problem
1
1
Patient Problem/Medical Problem
1
1
Fluid Discharge
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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