TPLC - Total Product Life Cycle

Device	accessories, soft lens products
Regulation Description	Soft (hydrophilic) contact lens care products.
Product Code	LPN
Regulation Number	886.5928
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED MEDICAL OPTICS
	SUBSTANTIALLY EQUIVALENT	3
ALCON
	SUBSTANTIALLY EQUIVALENT	15
ALLERGAN, INC.
	SUBSTANTIALLY EQUIVALENT	12
ALTAIRE PHARMACEUTICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	15
CIBA VISION
	SUBSTANTIALLY EQUIVALENT	15
OPTIKEM INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PFIZER
	SUBSTANTIALLY EQUIVALENT	1
SAUFLON PHARMACEUTICALS, LTD.
	SUBSTANTIALLY EQUIVALENT	4
SZABOCSIK AND ASSOCIATES
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Unknown (for use when the device problem is not known)	445
No Known Device Problem	298
Other (for use when an appropriate device code cannot be identified)	164
No Information	128
Contamination during use	32
Use of Device Issue	26
No code available	18
Device expiration issue	16
Material discolored	15
Device handling issue	14
Sterility	13
Leak	11
Bacterial contamination of device	7
Break	5
Tap water, use of	5
Device emits odor	5
Device operates differently than expected	5
Improper or incorrect procedure or method	5
Device or device component damaged by another device	4
Foreign material	4
Defective item	3
Disposable	3
Burst	2
Foreign material present in device	2
Residue after decontamination	2
Reaction	1
Tear, rip or hole in device packaging	1
Failure to obtain samples	1
Normal	1
Lens, toric	1
Disinfection, inadequate/improper	1
Incomplete or missing packaging	1
Labeling, missing	1
Instruction for use issue	1
Total Device Problems	1241

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Medical Optics Inc (AMO)	II	Nov-02-2010
2	Advanced Medical Optics, Inc.	I	Jul-19-2007
3	Advanced Medical Optics, Inc.	II	Mar-01-2007
4	Bausch & Lomb Inc	II	Nov-10-2009
5	Bausch & Lomb Inc	II	Aug-13-2009
6	Marietta Vision	III	Mar-04-2011