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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biomicroscope, slit-lamp, ac-powered
Regulation Description AC-powered slitlamp biomicroscope.
Product CodeHJO
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
ACHEVE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPASAMY ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 4
CANON
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 9
CSO
  SUBSTANTIALLY EQUIVALENT 1
HAAG-STREIT AG
  SUBSTANTIALLY EQUIVALENT 3
HUVITZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KEELER LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOWA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 2
REICHERT INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU 66 VISION-TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAKAGI SEIKO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TALIA TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 2
VISX, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 10
Use of Device Issue 5
Use of Incorrect Control Settings 4
Incorrect measurement 4
Tidal volume fluctuations 4
Device operates differently than expected 2
Computer software issue 1
Parameter calculation error due to software problem 1
Device displays error message 1
Programming issue 1
No Information 1
Total Device Problems 34

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

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Dec-01-2015
2 Carl Zeiss Meditec, Inc. II Nov-15-2013

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