TPLC - Total Product Life Cycle

Premarket Reviews
Manufacturer	Decision
ALLERGAN, INC.
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	4
BioVision Technologies, LLC
	SUBSTANTIALLY EQUIVALENT	2
CIBA VISION
	SUBSTANTIALLY EQUIVALENT	2
HOWARD INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
KERAVISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASERSIGHT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MILLENNIUM
	SUBSTANTIALLY EQUIVALENT	5
MORIA
	SUBSTANTIALLY EQUIVALENT	2
OASIS
	SUBSTANTIALLY EQUIVALENT	1
SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL SPECIALTIES CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	159
Normal	79
Contamination during use	43
Not Applicable	16
Other (for use when an appropriate device code cannot be identified)	14
Fire	8
Unknown (for use when the device problem is not known)	6
Suction issue	5
Device Issue	3
Failure to cut	3
Particulates	3
Unintended system motion	2
No Information	2
No code available	2
Optical distortion	1
Material perforation	1
Device damaged prior to use	1
Loss of power	1
Smoking	1
Device stops intermittently	1
Vacuum, loss of	1
Calibration error	1
Component(s), broken	1
Total Device Problems	354