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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device products, contact lens care, rigid gas permeable
Regulation Description Rigid gas permeable contact lens care products.
Product CodeMRC
Regulation Number 886.5918
Device Class 2


Premarket Reviews
ManufacturerDecision
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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