Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0740-04

FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile...

Alcon Laboratories / initiated 2004-03-11 / Terminated / root cause: labeling and UDI

Ciba Vision Corporation began a recall of FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION... on . The reason FDA records is "The lens inside the package does not match the prescription information labeled on the primary package". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0740-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
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.
Product code
LPM Lenses, Soft Contact, Extended Wear
Reason for recall
The lens inside the package does not match the prescription information labeled on the primary package.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignees were notified by letter on 3/11/2004.
Quantity in commerce
4461/6pk
Distribution
Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
Product codes and lots
Lot #063302, Exp. Date: 2006-08, Lot #088472, Exp. Date: 2008-07, Lot #073059, Exp. Date 2008-02, Lot #074338, Exp. Date: 2008-02.