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TPLC
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Device
products, contact lens care, rigid gas permeable
Product Code
MRC
Regulation Number
886.5918
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAUSCH & LOMB INCORPORATED
SUBSTANTIALLY EQUIVALENT
3
BAUSCH AND LOMB INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
CONTAMAC LTD.
SUBSTANTIALLY EQUIVALENT
1
DRY EYE INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
MENICON CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OMNIVISION AG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
2
2
2018
2
2
2019
1
1
2020
3
3
2021
1
1
2022
4
4
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7
7
Nonstandard Device
2
2
Improper or Incorrect Procedure or Method
2
2
Insufficient Information
1
1
Patient-Device Incompatibility
1
1
Patient Device Interaction Problem
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Material Opacification
1
1
Obstruction of Flow
1
1
Labelling, Instructions for Use or Training Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
5
5
Corneal Ulcer
4
4
Red Eye(s)
3
3
Corneal Abrasion
3
3
Irritation
3
3
Blurred Vision
3
3
Burning Sensation
2
2
Conjunctivitis
2
2
Visual Impairment
2
2
Eye Injury
2
2
Eye Infections
2
2
Corneal Clouding/Hazing
1
1
Unspecified Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Fungal Infection
1
1
Disability
1
1
Skin Inflammation/ Irritation
1
1
Dry Eye(s)
1
1
Inflammation
1
1
Itching Sensation
1
1
Eye Burn
1
1
Visual Disturbances
1
1
Swelling
1
1
Discomfort
1
1
Insufficient Information
1
1
Ulcer
1
1
Loss of Vision
1
1
Eye Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Contamac Solutions, Inc.
II
Oct-05-2021
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