TPLC - Total Product Life Cycle

• Device: instrument, vitreous aspiration and cutting, ac-powered
• Regulation Description: Vitreous aspiration and cutting instrument.
• Product Code: HQE
• Regulation Number: 886.4150
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALLERGAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
COHERENT INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERVISION
	SUBSTANTIALLY EQUIVALENT	7
HOWARD INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INSTRUMENT
	SUBSTANTIALLY EQUIVALENT	13
MICROLINE PENTAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIRA, INC.
	SUBSTANTIALLY EQUIVALENT	4
PEREGRINE SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	3
STAAR
	SUBSTANTIALLY EQUIVALENT	1
STORZ
	SUBSTANTIALLY EQUIVALENT	1
SYNERGETICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Burn of device or device component	71
Device Issue	58
Device displays error message	46
Unknown (for use when the device problem is not known)	42
Other (for use when an appropriate device code cannot be identified)	35
Failure to cut	22
Tip breakage	21
Particulates	12
Aspiration, incomplete	11
Device inoperable	10
Break	9
Loss of power	9
Noise	8
Vacuum, loss of	8
Smoking	6
Fitting problem	6
Failure to prime	6
Foreign material	5
Device emits odor	5
Difficult to insert	5
Inability to irrigate	5
Footswitch failure	4
Sticking	4
Aspiration issue	3
Component(s), broken	3
No display or display failure	3
Suction issue	3
Fluid leak	3
Device clogged	3
Failure to power-up	3
Device operational issue	3
Occlusion within device	3
No Known Device Problem	3
Rupture due to damage from surgical instrument	3
Unintended system motion	2
Rupture, cause unknown	2
Disconnection	2
Material separation	2
Sharp/jagged/rough/etched/scratched	2
Pressure issue	2
Component(s), overheating of	2
Poor quality image	1
Blank screen	1
Detachment of device component	1
Failure to infuse	1
Device stops intermittently	1
Overheating of device or device component	1
Component missing	1
Filling problem	1
Increase in suction	1
System fails to activate	1
Tube(s), splitting of	1
Tubing, incorrect placement of	1
Use of Device Issue	1
Detachment of device or device component	1
Dislodged or dislocated	1
No code available	1
Infusion or flow issue	1
Operating system becomes non-functional	1
Probe failure	1
Prompts will not clear	1
Spark	1
Device operates differently than expected	1
Bent	1
Calcified	1
Decrease in suction	1
Loose or intermittent connection	1
Tomographic pallet crack(s)	1
Dull	1
Malfunction	1
Total Device Problems	484

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Bausch & Lomb Inc	II	May-28-2010
2	Bausch & Lomb Inc	II	May-24-2007
3	Bausch & Lomb Inc	II	Apr-21-2007