Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0743-04

FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL...

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

Ciba Vision Corporation began a recall of FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL -0.75, AXIS 020, LOT ***, 2006-04, WJ, Wesley... 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-0743-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL -0.75, AXIS 020, LOT ***, 2006-04, WJ, Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plaines, IL 60018 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
10/6pk
Distribution
Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
Product codes and lots
Lot #072145, Exp. Date: 2006-04