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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
Regulation Description Rigid gas permeable contact lens care products.
Product CodeMRC
Regulation Number 886.5918
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMATRIX
  SUBSTANTIALLY EQUIVALENT 1
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 5
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 5
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SZABOCSIK AND ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 2
No Information 2
Unknown (for use when the device problem is not known) 1
Device operates differently than expected 1
Total Device Problems 6

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 1 0 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 Dec-22-2009

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