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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNR
Regulation Number 886.4350
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 2
  1.  K885230  MCDONALD FOLDING FORCEPS
  2.  K895434  ALCON FOLDING FORCEPS
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STAAR
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 18
Material fragmentation 11
Defective item 3
Tip breakage 2
Device inoperable 1
Misconnection 1
Human-Device Interface Issue 1
Device operates differently than expected 1
Inadequate service 1
No Known Device Problem 1
Particulates 1
Metal shedding debris 1
No code available 1
Component(s), broken 1
Other (for use when an appropriate device code cannot be identified) 1
Scratched material 1
Device Issue 1
Total Device Problems 47

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

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd III May-14-2008
2 Becton Dickinson and Company II Sep-19-2008

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