TPLC - Total Product Life Cycle

• Device: lenses, soft contact, daily wear
• Regulation Description: Soft (hydrophilic) contact lens.
• Product Code: LPL
• Regulation Number: 886.5925
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	3
ART OPTICAL CONTACT LENS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASPECT VISION CARE, LTD.
	SUBSTANTIALLY EQUIVALENT	5
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	10
BENZ RESEARCH AND DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	10
CIBA VISION
	SUBSTANTIALLY EQUIVALENT	13
CONTAMAC LTD.
	SUBSTANTIALLY EQUIVALENT	4
COOPERVISION
	SUBSTANTIALLY EQUIVALENT	27
INNOVA
	SUBSTANTIALLY EQUIVALENT	5
I-SEE VISION TECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	3
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	6
MENICON CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
OCULAR SCIENCES
	SUBSTANTIALLY EQUIVALENT	8
SAFILENS, S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SAUFLON PHARMACEUTICALS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNILENS CORP., USA
	SUBSTANTIALLY EQUIVALENT	13
VISTAKON
	SUBSTANTIALLY EQUIVALENT	13
WESTCON CONTACT LENS CO.
	SUBSTANTIALLY EQUIVALENT	1
X-CEL CONTACTS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Disposable	584
No Known Device Problem	50
No Information	26
Unknown (for use when the device problem is not known)	19
Defective item	3
Use of Device Issue	3
Tears, rips, holes in device, device material	3
Difficult to remove	2
Product quality issue	2
Torn material	2
Other (for use when an appropriate device code cannot be identified)	1
Lens, aspherical	1
Tap water, use of	1
Total Device Problems	697

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

Recalls
Manufacturer		Recall Class	Date Posted
1	CIBA Vision Puerto Rico, Inc.	II	Apr-13-2011
2	Ciba Vision Corporation	II	May-09-2007
3	Cooper Vision Caribbean Corp.	II	Jan-03-2013
4	CooperVision Inc.	I	Oct-14-2011
5	Coopervision Inc.	I	Jan-11-2012
6	Eyezone	II	Jan-11-2012
7	Johnson & Johnson Vision Care, Inc.	II	May-17-2013
8	Vistakon	III	Sep-18-2009