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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 1296
No Known Device Problem 730
Device operates differently than expected 82
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
Scratched material 5
Foreign material present in device 5
Mechanical issue 4
Noise, Audible 3
No Information 3
Device Issue 3
No code available 3
Particulates 3
Smoking 2
Retraction problem 2
Unintended system motion 2
Therapy delivered to incorrect body area 2
Poor quality image 1
Reflux within device 1
Use of Incorrect Control Settings 1
Loss of power 1
Out-of-box failure 1
Failure to power-up 1
Component(s), broken 1
Material perforation 1
Vacuum, loss of 1
Decrease in suction 1
Calibration error 1
Device damaged prior to use 1
Malposition of device 1
Erratic display 1
Burn of device or device component 1
Optical distortion 1
Device stops intermittently 1
Power source issue 1
Output energy incorrect 1
Expiration date error 1
Energy output to patient tissue incorrect 1
Total Device Problems 2398

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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