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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHMX
Regulation Number 886.4350
Device Class 1


Premarket Reviews
ManufacturerDecision
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INSTRUMENT
  SUBSTANTIALLY EQUIVALENT 1
MICROSULIS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Detachment of device or device component 5
No Known Device Problem 5
Break 4
Detachment of device component 3
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Dull 2
Foreign material present in device 2
Disconnection 2
Material fragmentation 2
Performance 1
Rupture due to damage from surgical instrument 1
Tip breakage 1
Metal shedding debris 1
Unintended ejection 1
Fluid leak 1
Foreign material 1
Material deformation 1
Material integrity issue 1
Dent in material 1
Sharp/jagged/rough/etched/scratched 1
Device damaged prior to use 1
Scratched material 1
No Information 1
Total Device Problems 45

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

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd III Aug-25-2007
2 Bausch and Lomb, Incorporated I Jan-17-2013
3 Beaver-Visitec International Inc. II May-27-2014
4 Becton Dickinson and Company II May-10-2011
5 Becton Dickinson and Company II Oct-03-2008
6 Ellex iScience, Inc. II Sep-04-2014
7 Hill-Rom, Inc. II Jun-19-2015
8 Insight Instruments, Inc. II May-10-2013
9 Synergetics Inc II Oct-22-2013

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