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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device products, contact lens care, rigid gas permeable
Product CodeMRC
Regulation Number 886.5918
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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
Obstruction of Flow 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 4 4
Pain 4 4
Red Eye(s) 3 3
Corneal Abrasion 3 3
Conjunctivitis 2 2
Eye Injury 2 2
Blurred Vision 2 2
Visual Impairment 2 2
Burning Sensation 2 2
Irritation 2 2
Eye Infections 2 2
Eye Pain 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Swelling 1 1
Disability 1 1
Fungal Infection 1 1
Eye Burn 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Corneal Clouding/Hazing 1 1
Unspecified Infection 1 1
Inflammation 1 1
Dry Eye(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Contamac Solutions, Inc. II Oct-05-2021
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