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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
79
79
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
171
171
Product Quality Problem
38
38
Device Markings/Labelling Problem
35
35
Contamination
30
30
Device Emits Odor
27
27
Patient-Device Incompatibility
24
24
Improper or Incorrect Procedure or Method
21
21
Labelling, Instructions for Use or Training Problem
13
13
Insufficient Information
13
13
Contamination /Decontamination Problem
8
8
Use of Device Problem
7
7
Device Handling Problem
6
6
Material Integrity Problem
5
5
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
4
4
No Apparent Adverse Event
4
4
Contamination of Device Ingredient or Reagent
4
4
Microbial Contamination of Device
3
3
Improper Chemical Reaction
3
3
Output Problem
3
3
Nonstandard Device
3
3
Fluid/Blood Leak
3
3
Defective Device
3
3
Break
2
2
Off-Label Use
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Component Missing
2
2
Fungus in Device Environment
2
2
Chemical Problem
2
2
Device Ingredient or Reagent Problem
1
1
Expiration Date Error
1
1
Inadequate User Interface
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Close
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Defective Component
1
1
Peeled/Delaminated
1
1
Difficult to Remove
1
1
Device Reprocessing Problem
1
1
Failure to Disinfect
1
1
Accessory Incompatible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burning Sensation
113
113
Red Eye(s)
68
68
Pain
66
66
Discomfort
44
44
Blurred Vision
43
43
Corneal Ulcer
42
42
Eye Burn
37
37
Irritation
34
34
Eye Pain
34
34
Keratitis
30
30
Excessive Tear Production
29
29
No Known Impact Or Consequence To Patient
26
26
Corneal Abrasion
25
25
No Clinical Signs, Symptoms or Conditions
24
24
Eye Infections
21
21
Dry Eye(s)
21
21
Corneal Scar
19
19
Conjunctivitis
17
17
Erythema
17
17
Loss of Vision
17
17
Swelling
16
16
Eye Injury
16
16
Hyperemia
16
16
Inflammation
15
15
Unspecified Infection
14
14
Itching Sensation
13
13
Corneal Edema
13
13
Foreign Body Sensation in Eye
12
12
Headache
12
12
Visual Impairment
12
12
No Code Available
12
12
Visual Disturbances
11
11
Caustic/Chemical Burns
10
10
Corneal Infiltrates
9
9
Swelling/ Edema
9
9
Insufficient Information
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Fungal Infection
7
7
Reaction
6
6
Discharge
6
6
Corneal Clouding/Hazing
6
6
Purulent Discharge
6
6
Erosion
5
5
Acanthameba Keratitis
5
5
Increased Sensitivity
5
5
Unspecified Eye / Vision Problem
5
5
Patient Problem/Medical Problem
5
5
Skin Inflammation/ Irritation
4
4
Fluid Discharge
4
4
Distress
4
4
Hypersensitivity/Allergic reaction
4
4
Intraocular Infection
3
3
Skin Irritation
3
3
Dizziness
3
3
Overwear Syndrome
3
3
Nausea
3
3
Foreign Body In Patient
3
3
Ptosis
2
2
Neovascularization
2
2
Skin Discoloration
2
2
Ulcer
2
2
Injury
2
2
Iritis
2
2
Hemorrhage/Bleeding
2
2
Bacterial Infection
2
2
Vitreous Floaters
2
2
Edema
1
1
Endophthalmitis
1
1
Exposure to Body Fluids
1
1
Abdominal Pain
1
1
Abscess
1
1
Burn(s)
1
1
Chemosis
1
1
Hypopyon
1
1
Laceration(s)
1
1
Miscarriage
1
1
Ischemia
1
1
Chemical Exposure
1
1
Weight Changes
1
1
No Consequences Or Impact To Patient
1
1
Halo
1
1
Scarring
1
1
Optical Nerve Damage
1
1
Local Reaction
1
1
Vitreous Hemorrhage
1
1
Phototoxicity
1
1
Chills
1
1
Uveitis
1
1
No Patient Involvement
1
1
No Information
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Increased Sensitivity
1
1
Localized Skin Lesion
1
1
Hallucination
1
1
Epistaxis
1
1
Unspecified Respiratory Problem
1
1
Corneal Epithelial Microcysts
1
1
Contact Dermatitis
1
1
Nodule
1
1
Reaction to Medicinal Component of Device
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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