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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 2014 2015 2016
4 6 3 3 6 6 14 18 14 2

Device Problems
No Known Device Problem 2817
Unknown (for use when the device problem is not known) 729
No Information 240
Device displays error message 217
Device operates differently than expected 141
Failure to fire 116
No code available 75
Output energy incorrect 69
Computer software issue 63
Failure to align 59
Improper or incorrect procedure or method 40
High Readings 31
Tracking 30
Inaccurate delivery 29
Use of Device Issue 25
Failure to capture 25
Overcorrection 24
Unintended movement 23
Other (for use when an appropriate device code cannot be identified) 23
Device inoperable 22
Use of Incorrect Control Settings 19
Unexpected therapeutic results 18
Failure to cut 18
Normal 17
Loss of power 17
Failure to sense 16
Optical obstruction 15
Inadequate lighting 14
Failure to deliver energy 14
Decrease in suction 13
Intermittent capture 12
Device stops intermittently 12
Suction issue 11
Gas leak 10
No display or display failure 9
Communication or transmission issue 8
Calibration issue 8
Patient-device incompatibility 7
Failure to advance 7
Energy output to patient tissue incorrect 7
Intermittent continuity 7
Device emits odor 7
Image display error 6
Failure to calibrate 6
Therapeutic or diagnostic output failure 5
Device Issue 5
Low readings 4
Leak 4
Energy spectrum incorrect 4
Incorrect measurement 4
Smoking 4
Unable to obtain readings 4
Inadequate training 3
Incorrect software programming calculations 3
No device output 3
Failure, intermittent 3
Defective item 3
Failure to deliver 3
Ambient noise issue 3
Programming issue 3
Improper device output 3
Mechanical jam 2
Reset issue 2
Output issue 2
Malposition of device 2
Device sensing issue 2
Inadequate user interface 2
Component missing 2
Fire 2
Incorrect display 2
Bent 2
Break 2
Difficult to position 2
Power Conditioning Issue 2
Failure to power-up 2
Unintended system motion 2
Unstable 2
Failure to read input signal 2
Failure to transmit record 2
Poor quality image 2
Sensing intermittently 2
Inappropriate shock 1
Shutter failure 1
Rupture due to capsulotomy 1
Self-activation or keying 1
Output above specifications 1
Mechanical issue 1
Misfocusing 1
Monitor failure 1
Device Difficult to Setup or Prepare 1
Difficult to Program or Calibrate 1
Therapy delivered to incorrect body area 1
Poor gas exchange 1
Burst 1
Calibration error 1
Charred 1
Detachment of device component 1
Computer hardware error 1
Application interface becomes non-functional or program exits abnormally 1
Failure to conduct 1
Total Device Problems 5196

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 0 0 0 0 0 0 0
Class II 0 4 0 0 2 0 2 1 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 Aug-09-2011
2 AMO Manufacturing USA, LLC II Feb-18-2011
3 Abbott Medical Optics, Inc. II Oct-22-2013
4 Abbott Medical Optics, Inc. II Jun-13-2013
5 Alcon Refractive Horizons, Inc. I Jun-05-2007
6 Nidek Inc II Jun-04-2015
7 Nidek Inc II Nov-17-2014
8 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Sep-17-2008
9 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Aug-20-2008
10 VISX INCORPORATED, A SUBSIDIARY OF AMO INC II Jun-05-2008
11 Visx Inc II Jan-23-2008

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