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TPLC
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show TPLC since
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Device
accessories, soft lens products
Product Code
LPN
Regulation Number
886.5928
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ALLERGAN, INC
SUBSTANTIALLY EQUIVALENT
1
BAUSCH & LOMB INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
CHEMTEX USA INC.
SUBSTANTIALLY EQUIVALENT
1
CHEMTEX USA, INC.
SUBSTANTIALLY EQUIVALENT
1
MENICON CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OTE NORTH AMERICA LLC
SUBSTANTIALLY EQUIVALENT
1
THE LIFESTYLE COMPANY, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
95
95
2019
60
60
2020
82
82
2021
50
50
2022
62
62
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
154
154
Device Markings/Labelling Problem
35
35
Product Quality Problem
31
31
Contamination
30
30
Improper or Incorrect Procedure or Method
21
21
Patient-Device Incompatibility
21
21
Labelling, Instructions for Use or Training Problem
13
13
Insufficient Information
12
12
Contamination /Decontamination Problem
8
8
Device Emits Odor
7
7
No Apparent Adverse Event
4
4
Patient Device Interaction Problem
4
4
Device Handling Problem
3
3
Material Integrity Problem
3
3
Improper Chemical Reaction
3
3
Output Problem
3
3
Use of Device Problem
3
3
Defective Device
3
3
Nonstandard Device
3
3
Break
2
2
Microbial Contamination of Device
2
2
Component Missing
2
2
Fungus in Device Environment
2
2
Off-Label Use
2
2
Chemical Problem
2
2
Contamination of Device Ingredient or Reagent
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Appropriate Term/Code Not Available
2
2
Inadequate User Interface
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Device Ingredient or Reagent Problem
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Close
1
1
Accessory Incompatible
1
1
Difficult to Remove
1
1
Defective Component
1
1
Device Reprocessing Problem
1
1
Failure to Disinfect
1
1
Fluid/Blood Leak
1
1
Peeled/Delaminated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burning Sensation
110
110
Pain
65
65
Red Eye(s)
60
60
Discomfort
38
38
Corneal Ulcer
38
38
Irritation
34
34
Keratitis
28
28
Blurred Vision
27
27
Eye Burn
26
26
No Known Impact Or Consequence To Patient
26
26
Excessive Tear Production
22
22
Eye Pain
20
20
Corneal Abrasion
18
18
Corneal Scar
17
17
No Clinical Signs, Symptoms or Conditions
17
17
Swelling
16
16
Erythema
15
15
Dry Eye(s)
14
14
Hyperemia
14
14
Inflammation
13
13
Eye Injury
13
13
Conjunctivitis
13
13
Corneal Edema
13
13
Unspecified Infection
12
12
No Code Available
12
12
Loss of Vision
11
11
Visual Impairment
10
10
Itching Sensation
10
10
Headache
9
9
Caustic/Chemical Burns
9
9
Eye Infections
9
9
Corneal Infiltrates
8
8
Discharge
6
6
Reaction
6
6
Foreign Body Sensation in Eye
6
6
Corneal Clouding/Hazing
6
6
Swelling/ Edema
6
6
Insufficient Information
5
5
Patient Problem/Medical Problem
5
5
Acanthameba Keratitis
5
5
Erosion
5
5
Fungal Infection
5
5
Increased Sensitivity
5
5
Visual Disturbances
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Foreign Body In Patient
3
3
Skin Irritation
3
3
Skin Inflammation/ Irritation
3
3
Nausea
3
3
Dizziness
3
3
Overwear Syndrome
3
3
Purulent Discharge
3
3
Intraocular Infection
3
3
Bacterial Infection
2
2
Ulcer
2
2
Injury
2
2
Unspecified Eye / Vision Problem
2
2
Fluid Discharge
2
2
Ptosis
2
2
No Patient Involvement
1
1
No Information
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Increased Sensitivity
1
1
Contact Dermatitis
1
1
Nodule
1
1
Reaction to Medicinal Component of Device
1
1
Hallucination
1
1
Corneal Epithelial Microcysts
1
1
Chemical Exposure
1
1
Weight Changes
1
1
No Consequences Or Impact To Patient
1
1
Halo
1
1
Neovascularization
1
1
Local Reaction
1
1
Skin Discoloration
1
1
Scarring
1
1
Vitreous Hemorrhage
1
1
Chills
1
1
Uveitis
1
1
Exposure to Body Fluids
1
1
Abdominal Pain
1
1
Abscess
1
1
Burn(s)
1
1
Chemosis
1
1
Vitreous Floaters
1
1
Edema
1
1
Endophthalmitis
1
1
Iritis
1
1
Hypopyon
1
1
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Miscarriage
1
1
Ischemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan PLC
II
Feb-03-2021
2
Family Dollar Stores, Llc.
II
Aug-17-2022
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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