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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device knife, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNN
Regulation Number 886.4350
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dull 785
Failure to cut 151
Bent 20
Particulates 18
Device operates differently than expected 18
No code available 17
Product quality issue 8
Other (for use when an appropriate device code cannot be identified) 7
Material deformation 7
No Known Device Problem 7
Metal shedding debris 5
Device damaged prior to use 5
Break 5
Mechanical issue 4
Misassembled 4
Tip breakage 4
Foreign material present in device 4
Unknown (for use when the device problem is not known) 3
Nonstandard device or device component 2
Scratched material 2
Device Issue 2
Device misassembled during manufacturing or shipping 2
Sharp/jagged/rough/etched/scratched 2
Calibration issue 1
Detachment of device or device component 1
Defective item 1
Dislodged or dislocated 1
Packaging issue 1
Mechanics altered 1
Difficult to remove 1
Device Difficult to Setup or Prepare 1
Defective component 1
Dent in material 1
Physical resistance 1
Total Device Problems 1093

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 3 1 0 0 1 0 0 0 0 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories, Inc II Mar-01-2007
2 Beaver-Visitec International Inc. II Apr-05-2011
3 Becton Dickinson and Company III May-13-2010
4 Becton Dickinson and Company II Feb-08-2007
5 Oasis Medical Inc II Jan-12-2008
6 Oasis Medical Inc II Jul-04-2007

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