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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 6
BENZ RESEARCH AND DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 5
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 5
NOVAVISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 9
SYNERGEYES, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
No Known Device Problem 18
Unknown (for use when the device problem is not known) 13
No code available 12
No Information 3
Crack 1
Difficult to remove 1
Use of Device Issue 1
Total Device Problems 49

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc II May-27-2010

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