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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device excimer laser system
Product CodeLZS
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
4 6 3 3 6 6 7

Device Problems
Unknown (for use when the device problem is not known) 729
No Known Device Problem 656
Device displays error message 137
No Information 129
Failure to fire 114
Computer software issue 63
Output energy incorrect 59
No code available 58
Failure to align 32
Tracking 30
Device operates differently than expected 29
Inaccurate delivery 28
High Readings 26
Other (for use when an appropriate device code cannot be identified) 23
Failure to capture 17
Normal 17
Optical obstruction 15
Inadequate lighting 14
Failure to sense 14
Device inoperable 13
Loss of power 12
Device stops intermittently 11
Unintended movement 11
Failure to deliver energy 9
No display or display failure 9
Communication or transmission issue 8
Failure to advance 7
Intermittent capture 7
Intermittent continuity 6
Calibration issue 6
Image display error 6
Device operational issue 6
Gas leak 5
Device emits odor 5
Use of Device Issue 5
Suction issue 5
Failure to calibrate 5
Unable to obtain readings 4
Ambient noise issue 3
Failure, intermittent 3
Failure to deliver 3
Overcorrection 3
Incorrect software programming calculations 3
Leak 3
Unexpected therapeutic results 3
Poor quality image 2
Unstable 2
Improper or incorrect procedure or method 2
Sensing intermittently 2
Failure to read input signal 2
Bent 2
Mechanical jam 2
Programming issue 2
Component missing 2
Defective item 2
Incorrect measurement 2
No device output 2
Difficult to position 2
Failure to transmit record 2
Premature discharge of battery 1
Calibration error 1
Monitor failure 1
Poor gas exchange 1
Failure to conduct 1
Decrease in suction 1
Unintended energization 1
Disconnection 1
Device Difficult to Setup or Prepare 1
Smoking 1
Break 1
Temperature issue 1
Capturing issue 1
Inadequate user interface 1
Output issue 1
Computer operating system issue 1
Operating system becomes non-functional 1
Burst 1
Computer hardware error 1
Use of Incorrect Control Settings 1
Fire 1
Laser output, unintended 1
Optical decentration 1
Failure to power-up 1
Shutter failure 1
Inadequate training 1
Device Issue 1
Power Conditioning Issue 1
Defective component 1
Miscalibration 1
Low readings 1
Issue with displayed error message 1
Medical Gas Supply problem 1
Reset issue 1
Total Device Problems 2413

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 1 0 0 0 0 0 0
Class II 0 4 0 0 2 0 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Aug-09-2011
2 AMO Manufacturing USA, LLC II Feb-18-2011
3 Abbott Medical Optics, Inc. II Jun-13-2013
4 Alcon Refractive Horizons, Inc. I Jun-05-2007
5 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Sep-17-2008
6 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Aug-20-2008
7 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Jun-05-2008
8 Visx Inc II Jan-23-2008

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