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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
accessories, soft lens products
Regulation Description
Soft (hydrophilic) contact lens care products.
Product Code
LPN
Regulation Number
886.5928
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2020
82
82
2021
50
50
2022
62
62
2023
85
85
2024
78
80
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
162
163
Device Emits Odor
28
28
Device Markings/Labelling Problem
20
20
Product Quality Problem
19
19
Contamination
18
18
Improper or Incorrect Procedure or Method
16
16
Labelling, Instructions for Use or Training Problem
12
12
Patient-Device Incompatibility
10
10
Insufficient Information
10
10
Use of Device Problem
7
7
Device Handling Problem
7
7
Appropriate Term/Code Not Available
6
6
Contamination /Decontamination Problem
5
5
Patient Device Interaction Problem
5
5
Contamination of Device Ingredient or Reagent
4
4
Output Problem
3
3
Material Integrity Problem
3
3
Improper Chemical Reaction
3
3
Fluid/Blood Leak
3
3
Chemical Problem
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Defective Device
2
2
Component Missing
2
2
Device Damaged by Another Device
2
2
Nonstandard Device
2
2
Fungus in Device Environment
2
2
Failure to Disinfect
2
2
Device Contaminated During Manufacture or Shipping
1
1
Break
1
1
Peeled/Delaminated
1
1
Expiration Date Error
1
1
Microbial Contamination of Device
1
1
Packaging Problem
1
1
Difficult to Open or Close
1
1
Inadequate User Interface
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Eye Pain
66
67
Red Eye(s)
60
60
Blurred Vision
55
55
Eye Burn
53
53
Corneal Ulcer
51
51
Burning Sensation
50
50
Discomfort
40
41
Excessive Tear Production
31
31
No Clinical Signs, Symptoms or Conditions
31
31
Keratitis
31
31
Eye Infections
29
29
Corneal Abrasion
26
26
Pain
23
23
Conjunctivitis
22
23
Hyperemia
20
21
Dry Eye(s)
20
20
Inflammation
18
18
Foreign Body Sensation in Eye
16
16
No Known Impact Or Consequence To Patient
16
16
Corneal Scar
16
16
Corneal Edema
16
16
Eye Injury
13
13
Swelling/ Edema
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
Loss of Vision
12
12
Irritation
12
12
Corneal Infiltrates
10
10
Visual Impairment
10
10
Headache
9
9
Caustic/Chemical Burns
9
9
Unspecified Infection
9
9
Corneal Clouding/Hazing
9
9
Purulent Discharge
8
8
Itching Sensation
8
8
Insufficient Information
8
8
Visual Disturbances
8
8
Erythema
8
8
Acanthameba Keratitis
7
7
Unspecified Eye / Vision Problem
7
7
Erosion
6
6
Hypersensitivity/Allergic reaction
6
6
No Code Available
5
5
Fungal Infection
5
5
Skin Inflammation/ Irritation
4
4
Distress
4
4
Overwear Syndrome
3
3
Ptosis
3
3
Hemorrhage/Bleeding
2
2
Vitreous Floaters
2
2
Fluid Discharge
2
2
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
-
-