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TPLC
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show TPLC since
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2024
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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
2019
60
60
2020
82
82
2021
50
50
2022
62
62
2023
85
85
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
143
143
Device Markings/Labelling Problem
28
28
Device Emits Odor
27
27
Contamination
26
26
Product Quality Problem
23
23
Improper or Incorrect Procedure or Method
16
16
Patient-Device Incompatibility
14
14
Labelling, Instructions for Use or Training Problem
13
13
Insufficient Information
11
11
Use of Device Problem
6
6
Device Handling Problem
6
6
Appropriate Term/Code Not Available
5
5
Contamination /Decontamination Problem
5
5
Contamination of Device Ingredient or Reagent
4
4
Patient Device Interaction Problem
4
4
Output Problem
3
3
Defective Device
3
3
Material Integrity Problem
3
3
Fungus in Device Environment
3
3
Fluid/Blood Leak
3
3
Nonstandard Device
2
2
Component Missing
2
2
Chemical Problem
2
2
Improper Chemical Reaction
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Inadequate User Interface
1
1
Device Contaminated During Manufacture or Shipping
1
1
Difficult to Open or Close
1
1
Packaging Problem
1
1
Expiration Date Error
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Difficult to Remove
1
1
Peeled/Delaminated
1
1
Break
1
1
Failure to Disinfect
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burning Sensation
77
77
Red Eye(s)
54
54
Eye Pain
40
40
Pain
39
39
Discomfort
38
38
Eye Burn
36
36
Corneal Ulcer
33
33
Blurred Vision
30
30
No Clinical Signs, Symptoms or Conditions
27
27
Keratitis
25
25
Excessive Tear Production
24
24
No Known Impact Or Consequence To Patient
24
24
Eye Infections
24
24
Irritation
23
23
Corneal Abrasion
21
21
Dry Eye(s)
18
18
Hyperemia
17
17
Inflammation
15
15
Conjunctivitis
15
15
Eye Injury
14
14
Corneal Scar
13
13
Loss of Vision
13
13
Erythema
12
12
Foreign Body Sensation in Eye
12
12
Corneal Edema
11
11
Swelling/ Edema
11
11
Unspecified Infection
10
10
Headache
9
9
Itching Sensation
9
9
Visual Disturbances
8
8
Corneal Infiltrates
8
8
Caustic/Chemical Burns
8
8
Insufficient Information
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Eye / Vision Problem
6
6
No Code Available
6
6
Swelling
6
6
Purulent Discharge
6
6
Corneal Clouding/Hazing
5
5
Hypersensitivity/Allergic reaction
5
5
Fungal Infection
5
5
Skin Inflammation/ Irritation
4
4
Visual Impairment
4
4
Discharge
4
4
Distress
4
4
Reaction
3
3
Fluid Discharge
3
3
Skin Irritation
3
3
Overwear Syndrome
3
3
Acanthameba Keratitis
3
3
Nausea
2
2
Hemorrhage/Bleeding
2
2
Iritis
2
2
Vitreous Floaters
2
2
Erosion
2
2
Increased Sensitivity
2
2
Skin Discoloration
2
2
Foreign Body In Patient
2
2
Patient Problem/Medical Problem
2
2
Chemical Exposure
2
2
Ptosis
2
2
Ulcer
2
2
Injury
2
2
Increased Sensitivity
2
2
Localized Skin Lesion
1
1
Skin Disorders
1
1
Contact Dermatitis
1
1
Nodule
1
1
Reaction to Medicinal Component of Device
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Hallucination
1
1
Epistaxis
1
1
Unspecified Respiratory Problem
1
1
Corneal Epithelial Microcysts
1
1
Uveitis
1
1
Vitreous Hemorrhage
1
1
Phototoxicity
1
1
Chills
1
1
Dizziness
1
1
Burn(s)
1
1
Abdominal Pain
1
1
Endophthalmitis
1
1
Intraocular Infection
1
1
Hypopyon
1
1
Neovascularization
1
1
Optical Nerve Damage
1
1
Rash
1
1
Local Reaction
1
1
Laceration(s)
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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