Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0793-2007

CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9...

Alcon Laboratories / initiated 2007-04-30 / Terminated

Ciba Vision Corporation began a recall of CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10 on . The reason FDA records is "Base curve of the lenses do not meet specification". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0793-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.
Product code
LPL Lenses, Soft Contact, Daily Wear
Reason for recall
Base curve of the lenses do not meet specification.
FDA root cause
Other
Action
Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
Quantity in commerce
22 lenses
Distribution
Nationwide.
Product codes and lots
Lot #41074100201110