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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 1396
No Known Device Problem 762
Device operates differently than expected 87
Normal 79
Contamination during use 43
Device displays error message 24
Failure to cut 22
Not Applicable 16
Other (for use when an appropriate device code cannot be identified) 14
Unexpected therapeutic results 13
Fire 8
Failure to advance 7
Unknown (for use when the device problem is not known) 6
Foreign material present in device 5
Scratched material 5
No code available 4
Mechanical issue 4
Particulates 3
Device Issue 3
Noise, Audible 3
No Information 3
Unintended system motion 2
Therapy delivered to incorrect body area 2
Retraction problem 2
Smoking 2
Device stops intermittently 1
Reflux within device 1
Output energy incorrect 1
Loss of power 1
Failure to power-up 1
Poor quality image 1
Burn of device or device component 1
Calibration error 1
Component(s), broken 1
Use of Incorrect Control Settings 1
Decrease in suction 1
Erratic display 1
Energy output to patient tissue incorrect 1
Malposition of device 1
Optical distortion 1
Power source issue 1
Material perforation 1
Device damaged prior to use 1
Out-of-box failure 1
Expiration date error 1
Vacuum, loss of 1
Total Device Problems 2536

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