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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
1. K202036
Focus DAILIES / Focus DAILIES Toric / Focus DAILIE
...
2. K202448
DAILIES AquaComfort Plus (DACP) / DACP FreshTech /
...
YUNG SHENG OPTICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
20
20
2015
10
10
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
153
153
Insufficient Information
27
27
Improper or Incorrect Procedure or Method
14
14
Defective Device
13
13
Patient-Device Incompatibility
12
12
Material Split, Cut or Torn
7
7
Product Quality Problem
6
6
Break
4
4
Torn Material
4
4
Entrapment of Device
3
3
Material Fragmentation
2
2
Use of Device Problem
2
2
Expiration Date Error
2
2
Material Rupture
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
Appropriate Term/Code Not Available
1
1
Packaging Problem
1
1
Material Separation
1
1
Sticking
1
1
Fitting Problem
1
1
Component Missing
1
1
Device Or Device Fragments Location Unknown
1
1
Particulates
1
1
Off-Label Use
1
1
Component Falling
1
1
Contamination
1
1
Difficult to Remove
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
87
87
Pain
66
66
Red Eye(s)
61
61
Unspecified Infection
28
28
Keratitis
28
28
Eye Injury
27
27
Eye Pain
25
25
Blurred Vision
24
24
Corneal Abrasion
24
24
Discomfort
23
23
Corneal Infiltrates
22
22
Eye Infections
22
22
Irritation
21
21
Corneal Scar
20
20
Corneal Edema
19
19
Loss of Vision
17
17
Visual Impairment
16
16
Discharge
15
15
Conjunctivitis
14
14
Acanthameba Keratitis
11
11
Excessive Tear Production
11
11
Burning Sensation
10
10
Inflammation
10
10
Foreign Body Sensation in Eye
10
10
Neovascularization
8
8
Bacterial Infection
8
8
Dry Eye(s)
7
7
Iritis
7
7
Ulcer
7
7
Scar Tissue
6
6
Headache
6
6
Erosion
5
5
Swelling
5
5
No Code Available
5
5
Fungal Infection
5
5
Visual Disturbances
4
4
Itching Sensation
4
4
Nausea
3
3
Corneal Stromal Edema
3
3
Purulent Discharge
3
3
Skin Inflammation/ Irritation
3
3
Swelling/ Edema
2
2
Intraocular Pressure Decreased
2
2
Device Embedded In Tissue or Plaque
2
2
Eye Burn
2
2
Reaction
2
2
Vomiting
2
2
Halo
2
2
Therapeutic Response, Decreased
2
2
Abscess
2
2
Hemorrhage/Bleeding
2
2
Corneal Clouding/Hazing
2
2
Hyphema
2
2
Hypopyon
2
2
Hyperemia
1
1
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
Anaphylactic Shock
1
1
Anoxia
1
1
Syncope
1
1
Abrasion
1
1
Erythema
1
1
Edema
1
1
Injury
1
1
Meningitis
1
1
Convulsion, Clonic
1
1
Uveitis
1
1
Staphylococcus Aureus
1
1
Collapse
1
1
Coma
1
1
Loss of consciousness
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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