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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, image management, ophthalmic
Regulation Description Picture archiving and communications system.
Product CodeNFJ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 6
DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAAG-STREIT AG
  SUBSTANTIALLY EQUIVALENT 1
KONAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Data Issue 10
Poor quality image 7
Image display error 6
Patient Data Issue 6
Device operates differently than expected 6
Loss of Data 3
Computer software issue 3
Device Issue 2
Application program issue 2
Programming issue 2
Improper device output 1
Connection issue 1
Disconnection 1
Improper or incorrect procedure or method 1
Total Device Problems 51

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 1 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 Bausch & Lomb Inc II May-26-2010
2 Carl Zeiss Meditec AG II Feb-04-2015

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