Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0703-03

Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in...

Alcon Laboratories / initiated 2003-03-17 / Terminated

Ciba Vision Corporation began a recall of Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials on . The reason FDA records is "The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0703-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
Product code
LPL Lenses, Soft Contact, Daily Wear
Reason for recall
The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
FDA root cause
Other
Action
The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.
Quantity in commerce
29,821 units
Distribution
Nationwide, Canada and Puerto Rico.
Product codes and lots
Green, PID Lot#NA, Button Lot#22940-32, Blue, PID Lot#40523337, Button Lot#22940-32, Bronze, PID Lot#40538359, Button Lot#22940-32, Violet, PID Lot#40522198, Button Lot #22940-32, Green, PID Lot#40581596, Button Lot#22985-95, Blue PID Lot 40550786, Button Lot#22620-19, Blue PID Lot#40505677, Button Lot#22620-20, Bronze PID Lot#40540880, Button Lot#22620-19, Violet, PID Lot#40543810, Button Lot#22620-19.