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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
Fitting problem 6
Failure to prime 6
Smoking 6
Difficult to insert 6
Inability to irrigate 5
Device emits odor 5
Foreign material 5
Footswitch failure 4
Sticking 4
No Known Device Problem 4
No code available 4
Aspiration issue 3
Suction issue 3
Rupture due to damage from surgical instrument 3
Fluid leak 3
Occlusion within device 3
Failure to power-up 3
No display or display failure 3
Device clogged 3
Component(s), broken 3
Detachment of device component 2
Component(s), overheating of 2
Disconnection 2
Unintended system motion 2
Material separation 2
Rupture, cause unknown 2
Sharp/jagged/rough/etched/scratched 2
Pressure issue 2
Device operates differently than expected 2
Dislodged or dislocated 1
Foreign material present in device 1
Infusion or flow issue 1
Material deformation 1
Operating system becomes non-functional 1
Spark 1
Detachment of device or device component 1
Dull 1
Malfunction 1
Prompts will not clear 1
Component missing 1
Failure to infuse 1
Vibration 1
Use of Device Issue 1
Tomographic pallet crack(s) 1
Tube(s), splitting of 1
Tubing, incorrect placement of 1
Probe failure 1
Device stops intermittently 1
Increase in suction 1
System fails to activate 1
Overheating of device or device component 1
Filling problem 1
Loose or intermittent connection 1
Poor quality image 1
Decrease in suction 1
Bent 1
Blank screen 1
Calcified 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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