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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, ophthalmic, ac-powered
Regulation Description Ophthalmic camera.
Product CodeHKI
Regulation Number 886.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
C.S.O. S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANON
  SUBSTANTIALLY EQUIVALENT 13
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 2
CLARITY MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
IMEDOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KONAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOWA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 12
MEDIVISION MEDICAL IMAGING, LTD.
  SUBSTANTIALLY EQUIVALENT 3
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 5
OPTICAL IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 2
OPTOVUE, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 7
UNITED INTEGRATED SERVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Image display error 17
Operating system becomes non-functional 11
Device Issue 9
Device inoperable 7
Connection issue 7
Device operates differently than expected 6
Computer operating system issue 4
Loss of Data 3
Device disinfection or sterilization issue 3
Device displays error message 3
Computer software issue 3
No device output 2
Image resolution poor 2
Application network issue 2
Application program issue 2
Use of Device Issue 2
Device stops intermittently 2
Programming issue 2
Patient Data Issue 2
Noise, Audible 1
Data Issue 1
Device sensing issue 1
No Known Device Problem 1
Operating system version or upgrade problem 1
Optical distortion 1
Power source issue 1
Problem with software installation 1
Fumes or vapors 1
Date-related software issue 1
Communication or transmission issue 1
Ambient noise issue 1
Loose or intermittent connection 1
Migration of device or device component 1
Poor quality image 1
Smoking 1
Sticking 1
Corrosion 1
Crack 1
Total Device Problems 108

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 1 3 0 0 2
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Clarity Medical Systems Inc II Mar-20-2014
2 Clarity Medical Systems Inc II Mar-07-2014
3 Clarity Medical Systems Inc II Feb-24-2012
4 Merge Healthcare, Inc. II Feb-06-2017
5 Merge Healthcare, Inc. II Jan-12-2017
6 Nidek Inc II Jul-02-2014
7 Nidek Inc II Aug-23-2013

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