TPLC - Total Product Life Cycle

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

Device Problems
Dull	792
Failure to cut	153
Bent	20
Particulates	19
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
Difficult to insert	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
Incorrect software programming calculations	1
Defective component	1
Dent in material	1
Physical resistance	1
Total Device Problems	1106

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