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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, trocar, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Definition The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
Product CodeNGY
Regulation Number 886.4350
Device Class 1


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

Device Problems
Leak 11
Break 2
Difficult to insert 2
Detachment of device component 1
Fluid leak 1
Dull 1
Device operates differently than expected 1
Total Device Problems 19

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

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories, Inc II May-26-2009
2 Alcon Research, LTD. II Sep-27-2012
3 Alcon Research, Ltd III Mar-13-2007
4 Alcon Research, Ltd. II May-18-2016

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