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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, ophthalmic
Regulation Description Ophthalmic laser.
Product CodeHQF
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 4
COHERENT INC.
  SUBSTANTIALLY EQUIVALENT 4
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 3
ELLEX, INC.
  SUBSTANTIALLY EQUIVALENT 6
IRIDEX CORP.
  SUBSTANTIALLY EQUIVALENT 4
LIGHTMED CORP.
  SUBSTANTIALLY EQUIVALENT 9
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 3
OPTIMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Normal 46
Device operates differently than expected 43
Device displays error message 38
No code available 23
Loss of power 16
Failure to deliver energy 15
No Known Device Problem 12
Failure to fire 12
Output energy incorrect 11
Unexpected therapeutic results 11
Misfocusing 9
Output below specifications 9
Output issue 8
Device inoperable 8
Other (for use when an appropriate device code cannot be identified) 7
Operating system becomes non-functional 7
Power source issue 6
Energy output to patient tissue incorrect 6
Smoking 4
Sticking 4
Failure to power-up 4
Self-activation or keying 4
Fitting problem 4
Defective component 3
Device emits odor 3
Nonstandard device or device component 2
Hybrid failure 2
Disconnection 2
No display or display failure 2
Break 2
Continuous firing 2
Overheating of device or device component 2
Use of Device Issue 2
Device Issue 2
Prompts will not clear 2
Misfire 2
Calibration issue 2
Component or accessory incompatibility 2
Improper device output 2
No Information 2
Protective measure issue 2
Temperature issue 1
Device handling issue 1
Inadequate user interface 1
Environmental Particulates 1
Failure to shut off 1
Application program issue 1
Defective item 1
Spark 1
Device damaged prior to use 1
Loss of osseointegration 1
Improper or incorrect procedure or method 1
Suction issue 1
Unknown (for use when the device problem is not known) 1
Pitted 1
Output above specifications 1
Output, low 1
Material separation 1
Difficult to remove 1
Use of Incorrect Control Settings 1
Application interface becomes non-functional or program exits abnormally 1
Component(s), broken 1
Computer software issue 1
Blank screen 1
Inadequate instructions for healthcare professional 1
Laser output, unintended 1
Fail-safe design failure 1
Filter 1
Total Device Problems 372

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 4 1 0 1 7 2 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories, Inc. II Nov-06-2008
2 Bausch & Lomb Inc II Dec-23-2014
3 Bausch & Lomb Inc II May-28-2010
4 Carl Zeiss Meditec AG II Mar-07-2014
5 Ellex Medical Pty Ltd II Apr-12-2011
6 Ellex Medical Pty Ltd II Jan-20-2010
7 Ellex USA II Dec-20-2007
8 Laserex Systems Inc. II Apr-07-2016
9 Lumenis, Inc. II Sep-30-2014
10 Lumenis, Inc. II Sep-30-2010
11 Nidek Inc II Feb-19-2015
12 Nidek Inc II Nov-17-2014
13 Nidek Inc II Nov-17-2014
14 Nidek Inc II Jul-30-2014
15 Peregrine Surgical Ltd II Sep-11-2010
16 Topcon Medical Laser Systems, Inc II Aug-11-2016
17 Topcon Medical Laser Systems, Inc II Jul-19-2013
18 Ziemer Usa Inc II Jan-15-2015
19 Ziemer Usa Inc II Jan-23-2014

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