TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ALCON
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOPERVISION
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
DEROYAL
	SUBSTANTIALLY EQUIVALENT	1
ETHICON
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Dull	434
Failure to cut	53
Particulates	18
No code available	15
Bent	10
Other (for use when an appropriate device code cannot be identified)	7
Tip breakage	4
Metal shedding debris	4
Device damaged prior to use	4
Unknown (for use when the device problem is not known)	3
Break	3
No Known Device Problem	3
Device Issue	2
Product quality issue	2
Sharp/jagged/rough/etched/scratched	2
Calibration issue	1
Device operational issue	1
Dislodged or dislocated	1
Foreign material present in device	1
Material deformation	1
Defective component	1
Dent in material	1
Difficult to remove	1
Misassembled	1
Packaging issue	1
Defective item	1
Total Device Problems	575

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	3	1	0	0	1	0	0
Class III	0	0	0	1	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