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TPLC
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Device
products, contact lens care, rigid gas permeable
Regulation Description
Rigid gas permeable contact lens care products.
Product Code
MRC
Regulation Number
886.5918
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAUSCH & LOMB INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
DRY EYE INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
3
3
2021
1
1
2022
4
4
2023
2
2
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Nonstandard Device
2
2
Patient Device Interaction Problem
1
1
Insufficient Information
1
1
Patient-Device Incompatibility
1
1
Labelling, Instructions for Use or Training Problem
1
1
Obstruction of Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Red Eye(s)
4
4
Corneal Ulcer
4
4
Eye Infections
3
3
Eye Pain
3
3
Eye Injury
2
2
Anaphylactic Shock
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Blurred Vision
1
1
Corneal Abrasion
1
1
Skin Inflammation/ Irritation
1
1
Dry Eye(s)
1
1
Pain
1
1
Insufficient Information
1
1
Unspecified Infection
1
1
Irritation
1
1
Corneal Clouding/Hazing
1
1
Burning Sensation
1
1
Fungal Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Contamac Solutions, Inc.
II
Oct-05-2021
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