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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, vitreous aspiration and cutting, ac-powered
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeHQE
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
COHERENT INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 7
HOWARD INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INSTRUMENT
  SUBSTANTIALLY EQUIVALENT 13
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
STAAR
  SUBSTANTIALLY EQUIVALENT 1
STORZ
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Burn of device or device component 71
Device Issue 59
Device displays error message 46
Unknown (for use when the device problem is not known) 42
Other (for use when an appropriate device code cannot be identified) 35
Failure to cut 25
Tip breakage 21
Particulates 13
Aspiration, incomplete 11
Device inoperable 10
Break 9
Loss of power 9
Vacuum, loss of 8
Noise 8
Failure to prime 6
Smoking 6
Difficult to insert 6
Fitting problem 6
Device emits odor 5
Inability to irrigate 5
Foreign material 5
No code available 4
No Known Device Problem 4
Footswitch failure 4
Sticking 4
Aspiration issue 3
Device clogged 3
Failure to power-up 3
Rupture due to damage from surgical instrument 3
Component(s), broken 3
Fluid leak 3
Occlusion within device 3
No display or display failure 3
Suction issue 3
Unintended system motion 2
Device operates differently than expected 2
Component(s), overheating of 2
Disconnection 2
Rupture, cause unknown 2
Material separation 2
Pressure issue 2
Sharp/jagged/rough/etched/scratched 2
Detachment of device component 2
Poor quality image 1
Failure to infuse 1
Foreign material present in device 1
Material deformation 1
Probe failure 1
Tomographic pallet crack(s) 1
Dull 1
Malfunction 1
Loose or intermittent connection 1
Decrease in suction 1
Overheating of device or device component 1
Tubing, incorrect placement of 1
Detachment of device or device component 1
Filling problem 1
Device stops intermittently 1
Vibration 1
Blank screen 1
Prompts will not clear 1
Spark 1
Bent 1
Calcified 1
Infusion or flow issue 1
Operating system becomes non-functional 1
Component missing 1
Increase in suction 1
System fails to activate 1
Tube(s), splitting of 1
Use of Device Issue 1
Dislodged or dislocated 1
Total Device Problems 496

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

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Grieshaber AG II Jun-06-2013
2 Bausch & Lomb Inc II May-28-2010
3 Bausch & Lomb Inc II May-24-2007
4 Bausch & Lomb Inc II Apr-21-2007

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