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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, phacofragmentation
Regulation Description Phacofragmentation system.
Product CodeHQC
Regulation Number 886.4670
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 2
ALCON
  SUBSTANTIALLY EQUIVALENT 14
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 6
AMERICAN OPTISURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 9
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 15
D.O.R.C. INTL. B.V.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 2
LENSTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INSTRUMENT
  SUBSTANTIALLY EQUIVALENT 2
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICROSULIS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
STAAR
  SUBSTANTIALLY EQUIVALENT 6
STORZ
  SUBSTANTIALLY EQUIVALENT 2
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 3004
Failure to cut 1479
No code available 1244
Aspiration issue 1178
No Known Device Problem 1168
Device operates differently than expected 815
Device inoperable 721
Loss of power 720
Operating system becomes non-functional 414
Occlusion within device 368
Suction issue 330
Difficult to insert 329
Fluid leak 291
Infusion or flow issue 270
No display or display failure 244
Burn of device or device component 230
Unknown (for use when the device problem is not known) 205
Inability to irrigate 198
Failure to prime 181
Break 171
Device Issue 167
Fitting problem 162
Pressure issue 155
Device clogged 147
No Information 144
Failure to power-up 128
Particulates 120
Prompts will not clear 119
Decrease in suction 114
Failure to infuse 111
Other (for use when an appropriate device code cannot be identified) 108
Inadequate lighting 99
Device stops intermittently 94
Insufficient flow or underinfusion 89
Sticking 83
Leak 79
Foreign material present in device 76
Overheating of device or device component 74
No flow 72
Connection issue 69
Reflux within device 67
Material frayed 64
Decrease in pressure 59
Loose or intermittent connection 57
Blockage within device or device component 50
Disconnection 49
Obstruction within device 49
Footswitch failure 47
Excess flow or overinfusion 44
Aspiration, incomplete 43
Kinked 42
Use of Device Issue 41
Detachment of device component 40
Device emits odor 37
Improper flow or infusion 36
Smoking 35
Metal shedding debris 34
Detachment of device or device component 30
Power source issue 29
Bent 28
Application interface becomes non-functional or program exits abnormally 27
Electrical issue 27
Defective item 25
Defective component 25
Vibration 24
Device Cleaning Issue 24
Material separation 23
Ambient noise issue 22
Noise, Audible 22
Optical issue 20
Incorrect display 19
Failure to deliver energy 19
Computer operating system issue 18
Communication or transmission issue 18
Free or unrestricted flow 18
Self-activation or keying 18
Noise 18
Dull 18
Difficult to remove 17
Difficult to position 17
Material fragmentation 17
Output below specifications 17
Increase in suction 16
Vacuum, loss of 16
Unstable 15
Device sensing issue 15
Erratic display 15
Intermittent continuity 15
No Pressure 15
Mechanical issue 14
Heat 13
Use of Incorrect Control Settings 13
Air leak 13
Material integrity issue 13
Failure to shut off 12
Tip breakage 12
Improper or incorrect procedure or method 12
Restricted flowrate 12
Peeled 12
Hole in material 11
Total Device Problems 17348

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 1 1 1 1 1 1 1 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics, Inc. II Jul-09-2013
2 Advanced Medical Optics, Inc. II Aug-25-2008
3 Alcon Research LTD dba Alcon Laboratories, Inc. I Jul-13-2010
4 Alcon Research, Ltd. II Jun-09-2016
5 Alcon Research, Ltd. II May-03-2016
6 Alcon Research, Ltd. II Jun-29-2015
7 Alcon Research, Ltd. II Dec-04-2014
8 American Optisurgical Inc II Sep-04-2009
9 Bausch & Lomb Inc II Dec-20-2012
10 Bausch & Lomb Inc II Aug-30-2011
11 Bausch & Lomb Inc II May-28-2010

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