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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device refractometer, ophthalmic
Regulation Description Ophthalmic refractometer.
Product CodeHKO
Regulation Number 886.1760
Device Class 1


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON
  SUBSTANTIALLY EQUIVALENT 4
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 1
VISX, INCORPORATED
  SE - WITH LIMITATIONS 1

Device Problems
No Known Device Problem 16
Smoking 5
Incorrect measurement 2
Loss of power 2
Incorrect software programming calculations 2
Image display error 2
Device operates differently than expected 2
Laser output, unintended 1
Burn of device or device component 1
Computer software issue 1
Unexpected therapeutic results 1
Device displays error message 1
Total Device Problems 36

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

Recalls
Manufacturer Recall Class Date Posted
1 Canon Inc. II May-25-2013
2 Nidek Inc II Aug-27-2015

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