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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device lens, contact (other material) - daily
Regulation Description Rigid gas permeable contact lens.
Product CodeHQD
Regulation Number 886.5916
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED VISION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON FOUNDATION FOR SIGHT
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEYES, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 7
Appropriate Term/Code Not Available 1
Use of Device Problem 1
Insufficient Information 1
Total Device Problems 10

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical III Sep-06-2018

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