Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0182-06

AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz...

Alcon Laboratories / initiated 2005-11-02 / Terminated / root cause: sterility

Ciba Vision Corporation began a recall of AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada... on . The reason FDA records is "Lack of assurance of sterility at the time of manufacture". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-0182-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA
Product code
MRC Products, Contact Lens Care, Rigid Gas Permeable
Reason for recall
Lack of assurance of sterility at the time of manufacture.
Root cause tag
sterility
FDA root cause
Other
Action
Consignees were contacted by telephone with a follow up letter 11/04/2005.
Quantity in commerce
29592 cases (24 units per case)
Distribution
Nationwide, Canada, Germany, Benelux, and the UK
Product codes and lots
Lot #52246