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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Regulation Description Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Product CodeLXS
Regulation Number 886.4392
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unexpected therapeutic results 8
Misfocusing 5
Nonstandard device or device component 5
Output energy incorrect 3
Device operates differently than expected 3
Material integrity issue 2
Mechanics altered 2
Energy output to patient tissue incorrect 2
Optical issue 2
Device inoperable 1
Failure to fire 1
No Known Device Problem 1
Output above specifications 1
Total Device Problems 36

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

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Apr-02-2015

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