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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, irrigation, ocular surgery
Regulation Description Ocular surgery irrigation device.
Product CodeKYG
Regulation Number 886.4360
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
STAAR
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dull 275
Foreign material present in device 179
No Known Device Problem 107
Fitting problem 90
Failure to cut 64
Device Issue 64
Foreign material 55
Fluid leak 54
Disconnection 44
Unknown (for use when the device problem is not known) 33
Particulates 30
Connection issue 29
Detachment of device component 28
Detachment of device or device component 21
No code available 20
Leak 19
Dislodged or dislocated 15
Break 13
Sticking 13
Device operates differently than expected 12
Loose or intermittent connection 11
Bent 9
Tip breakage 9
Product quality issue 8
Unintended ejection 8
Material deformation 7
No Information 7
Difficult to insert 6
Metal shedding debris 6
Other (for use when an appropriate device code cannot be identified) 5
Component missing 5
Device misassembled during manufacturing or shipping 5
Mislabeled 5
Material fragmentation 4
Incorrect device or component shipped 4
Kinked 4
Defective component 4
Material separation 4
Packaging issue 4
Positioning Issue 4
Torn material 3
Use of Device Issue 3
Infusion or flow issue 3
Aspiration issue 3
Migration of device or device component 3
Occlusion within device 3
Aspiration, excessive 3
Aspiration, incomplete 2
Blockage within device or device component 2
Collapse 2
Device emits odor 2
Unintended system motion 2
Nonstandard device or device component 2
Misassembled 2
Insufficient flow or underinfusion 2
Scratched material 2
Material Distortion 2
Material integrity issue 2
Material twisted 2
Optical discoloration 2
Material Protrusion 1
Unintended movement 1
Pressure issue 1
Protective measure issue 1
Vacuum, loss of 1
Slippage of device or device component 1
Device inoperable 1
Failure to infuse 1
Device damaged prior to use 1
Defective item 1
Obstruction within device 1
Structural problem 1
Split 1
Physical resistance 1
Light interference 1
Improper flow or infusion 1
Inadequate lighting 1
Difficult to open or close 1
Loose 1
Hole in material 1
Inability to irrigate 1
Device Difficult to Setup or Prepare 1
Failure to prime 1
User used incorrect product for intended use 1
Disposable 1
Fracture 1
Crack 1
Disassembly 1
Material discolored 1
Total Device Problems 1360

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 1 0 0 1 0 0 0 0 0 0
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson and Company III Mar-29-2007
2 Insight Instruments, Inc. II Aug-13-2010
3 Oasis Medical Inc II Jun-27-2007

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