FDA Recall Terminated

FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA. Product is packed in 6 packs.

Recall: Z-0740-04 · Initiated March 11, 2004

Recall

Recall Number
Z-0740-04
Event Number
28542
Firm
Ciba Vision Corporation
FEI Number
1053053
Product Code
LPM
Status
Terminated
Root Cause
Other
Initiated
March 11, 2004
Posted
July 20, 2004
Terminated
November 16, 2005
Address
11440 Johns Creek Pkwy, Duluth, GA, 30097-1518

Description

FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA. Product is packed in 6 packs.

Reason

The lens inside the package does not match the prescription information labeled on the primary package.

Action

Consignees were notified by letter on 3/11/2004.

Distribution

Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.

Quantity

4461/6pk