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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device keratome, ac-powered
Regulation Description Keratome.
Product CodeHNO
Regulation Number 886.4370
Device Class 1


Premarket Reviews
ManufacturerDecision
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 4
BioVision Technologies, LLC
  SUBSTANTIALLY EQUIVALENT 2
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 2
HOWARD INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
KERAVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASERSIGHT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 5
MORIA
  SUBSTANTIALLY EQUIVALENT 2
OASIS
  SUBSTANTIALLY EQUIVALENT 1
SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction issue 749
No Known Device Problem 507
Normal 79
Device operates differently than expected 59
Contamination during use 43
Failure to cut 21
Not Applicable 16
Other (for use when an appropriate device code cannot be identified) 14
Unexpected therapeutic results 13
Fire 8
Device displays error message 8
Failure to advance 7
Unknown (for use when the device problem is not known) 6
Scratched material 5
No Information 3
No code available 3
Noise, Audible 3
Device Issue 3
Particulates 3
Smoking 2
Unintended system motion 2
Output energy incorrect 1
Poor quality image 1
Erratic display 1
Energy output to patient tissue incorrect 1
Calibration error 1
Component(s), broken 1
Device stops intermittently 1
Vacuum, loss of 1
Loss of power 1
Failure to power-up 1
Therapy delivered to incorrect body area 1
Malposition of device 1
Material perforation 1
Device damaged prior to use 1
Out-of-box failure 1
Optical distortion 1
Total Device Problems 1570

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 1 1 0 0 2 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Nov-04-2011
2 Bausch & Lomb Inc II Oct-22-2008
3 Bausch & Lomb Inc II Aug-02-2007
4 Med-logics Inc II Mar-13-2015
5 Wavelight AG II May-25-2011

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