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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 3023
Failure to cut 1522
No code available 1245
Aspiration issue 1180
No Known Device Problem 1170
Device operates differently than expected 820
Device inoperable 727
Loss of power 722
Operating system becomes non-functional 414
Occlusion within device 368
Difficult to insert 344
Suction issue 331
Fluid leak 291
Infusion or flow issue 270
No display or display failure 249
Burn of device or device component 230
Unknown (for use when the device problem is not known) 205
Inability to irrigate 199
Failure to prime 181
Break 172
Device Issue 167
Fitting problem 162
Pressure issue 155
Device clogged 147
No Information 144
Failure to power-up 128
Particulates 123
Prompts will not clear 119
Decrease in suction 115
Failure to infuse 111
Other (for use when an appropriate device code cannot be identified) 108
Reflux within device 102
Inadequate lighting 99
Device stops intermittently 94
Insufficient flow or underinfusion 89
Sticking 83
Foreign material present in device 81
Leak 79
Overheating of device or device component 75
No flow 73
Connection issue 69
Material frayed 67
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
Smoking 36
Improper flow or infusion 36
Metal shedding debris 34
Detachment of device or device component 30
Power source issue 30
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 23
Noise, Audible 23
Optical issue 20
Incorrect display 20
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
Increase in suction 17
Difficult to remove 17
Difficult to position 17
Material fragmentation 17
Output below specifications 17
Erratic display 16
Vacuum, loss of 16
Unstable 15
Device sensing issue 15
Intermittent continuity 15
No Pressure 15
Mechanical issue 14
Heat 13
Peeled 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
Hole in material 11
Total Device Problems 17508

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 3
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-28-2016
5 Alcon Research, Ltd. II Jun-09-2016
6 Alcon Research, Ltd. II May-03-2016
7 Alcon Research, Ltd. II Jun-29-2015
8 Alcon Research, Ltd. II Dec-04-2014
9 American Optisurgical Inc II Sep-04-2009
10 Bausch & Lomb Inc II Dec-20-2012
11 Bausch & Lomb Inc II Aug-30-2011
12 Bausch & Lomb Inc II May-28-2010

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