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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, solution, ultrasonic cleaners for lenses
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLYL
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 27
No code available 6
Device misassembled during manufacturing or shipping 3
Unknown (for use when the device problem is not known) 1
Defective item 1
Chemical issue 1
Total Device Problems 39

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 1 0 0 1 1 0 0 2 0 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc III Aug-19-2011
2 Bausch & Lomb Inc II Feb-02-2011
3 Bausch & Lomb Inc II Apr-04-2007
4 Bausch & Lomb Inc- Greenville Solutions Plant II Oct-24-2014
5 Bausch & Lomb Inc- Greenville Solutions Plant II May-06-2014
6 K C Pharmaceuticals Inc II Apr-02-2010

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