TPLC - Total Product Life Cycle

• Device: unit, phacofragmentation
• Regulation Description: Phacofragmentation system.
• Product Code: HQC
• Regulation Number: 886.4670
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCED MEDICAL OPTICS
	SUBSTANTIALLY EQUIVALENT	2
ALCON
	SUBSTANTIALLY EQUIVALENT	14
ALLERGAN, INC.
	SUBSTANTIALLY EQUIVALENT	6
AMERICAN OPTISURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	7
COOPERVISION
	SUBSTANTIALLY EQUIVALENT	15
D.O.R.C. INTL. B.V.
	SUBSTANTIALLY EQUIVALENT	1
DRAVON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	1
LENSTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INSTRUMENT
	SUBSTANTIALLY EQUIVALENT	2
MENTOR CORP.
	SUBSTANTIALLY EQUIVALENT	1
MICROSULIS MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
STAAR
	SUBSTANTIALLY EQUIVALENT	6
STORZ
	SUBSTANTIALLY EQUIVALENT	2
SYNERGETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device displays error message	1934
No code available	802
Failure to cut	715
No Known Device Problem	585
Aspiration issue	578
Device operational issue	509
Loss of power	346
Device inoperable	315
Burn of device or device component	217
Unknown (for use when the device problem is not known)	205
Fluid leak	188
Operating system becomes non-functional	181
Device operates differently than expected	178
No display or display failure	163
Occlusion within device	151
Fitting problem	137
Failure to prime	133
Inability to irrigate	114
Other (for use when an appropriate device code cannot be identified)	108
Infusion or flow issue	102
Suction issue	97
Prompts will not clear	95
Device Issue	91
Break	90
Pressure issue	75
Particulates	71
Device stops intermittently	70
Sticking	69
Failure to infuse	69
Device clogged	63
Failure to power-up	63
Difficult to insert	57
Insufficient flow or underinfusion	55
No Information	51
Reflux within device	49
Footswitch failure	47
Overheating of device or device component	43
Aspiration, incomplete	43
Inadequate lighting	41
Decrease in pressure	41
Connection issue	32
Disconnection	31
Blockage within device or device component	31
Foreign material present in device	31
No flow	31
Loose or intermittent connection	31
Obstruction within device	30
Smoking	27
Decrease in suction	24
Device emits odor	24
Vibration	22
Detachment of device component	22
Improper flow or infusion	22
Material separation	21
Device Cleaning Issue	19
Noise	18
Excess flow or overinfusion	18
Use of Device Issue	17
Leak	16
Vacuum, loss of	16
Kinked	16
Dull	15
Defective component	15
Metal shedding debris	15
Ambient noise issue	14
Increase in suction	13
Heat	13
Free or unrestricted flow	13
Erratic display	13
Bent	12
Detachment of device or device component	12
Tip breakage	12
Output below specifications	11
Use of Incorrect Control Settings	10
Unintended ejection	10
Foreign material	10
Restricted flowrate	9
Performance	9
Failure to shut off	9
Delivered as unsterile product	9
Failure to calibrate	8
Rupture due to damage from surgical instrument	8
No device output	8
Component(s), broken	8
Rejection	8
Device misassembled during manufacturing or shipping	8
Dislodged or dislocated	8
Unintended system motion	8
Increase in pressure	8
Power Conditioning Issue	8
Intermittent continuity	7
Incorrect display	7
Difficult or delayed activation	7
Product quality issue	6
Malfunction	6
Aspiration, excessive	6
Intermittent infusion	6
Difficult to remove	6
No Pressure	5
Failure to cycle	5
Total Device Problems	9805

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Medical Optics, Inc.	II	Aug-25-2008
2	Alcon Research LTD dba Alcon Laboratories, Inc.	I	Jul-13-2010
3	American Optisurgical Inc	II	Sep-04-2009
4	Bausch & Lomb Inc	II	Dec-20-2012
5	Bausch & Lomb Inc	II	Aug-30-2011
6	Bausch & Lomb Inc	II	May-28-2010