TPLC - Total Product Life Cycle

Premarket Reviews
Manufacturer	Decision
ALCON
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORP.
	SUBSTANTIALLY EQUIVALENT	2
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	4
COHERENT INC.
	SUBSTANTIALLY EQUIVALENT	4
COOPERVISION
	SUBSTANTIALLY EQUIVALENT	3
ELLEX, INC.
	SUBSTANTIALLY EQUIVALENT	4
IRIDEX CORP.
	SUBSTANTIALLY EQUIVALENT	4
LIGHTMED CORP.
	SUBSTANTIALLY EQUIVALENT	7
LUMENIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MERIDIAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRA, INC.
	SUBSTANTIALLY EQUIVALENT	4
NIDEK CO
	SUBSTANTIALLY EQUIVALENT	1
OPTIMEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PEREGRINE SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	7
SURGICAL LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Normal	46
Device displays error message	29
No code available	14
Device operates differently than expected	12
Device operational issue	9
Loss of power	8
Other (for use when an appropriate device code cannot be identified)	7
Device inoperable	5
Failure to fire	5
Output energy incorrect	4
Energy output to patient tissue incorrect	4
Operating system becomes non-functional	4
Output below specifications	3
Failure to power-up	3
Smoking	3
Device emits odor	3
Hybrid failure	2
Break	2
Fitting problem	2
Prompts will not clear	2
Device Issue	2
Misfire	2
Defective item	1
Loss of osseointegration	1
Calibration issue	1
Improper device output	1
Blank screen	1
Unknown (for use when the device problem is not known)	1
Output, low	1
Pitted	1
Use of Device Issue	1
Component(s), broken	1
Disconnection	1
No display or display failure	1
Failure to deliver energy	1
Fail-safe design failure	1
Filter	1
Laser output, unintended	1
Misfocusing	1
Sticking	1
Total Device Problems	189