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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, phacoemulsification, reprocessed
Regulation Description Phacofragmentation system.
Definition Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle.
Product CodeNKX
Regulation Number 886.4670
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Detachment of device component 1
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc II Sep-16-2008
2 Sterilmed Inc II Jan-13-2009

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