Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1402-06

Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision

Alcon Laboratories / initiated 2006-07-25 / Terminated / root cause: labeling and UDI

Ciba Vision Corporation began a recall of Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision on . The reason FDA records is "Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50)". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1402-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision
Product code
LPL Lenses, Soft Contact, Daily Wear
Reason for recall
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignees were notified by letter on/about 07/25/06 to return any of the affected lots found in inventory
Quantity in commerce
86 (approx 1000 lenses) packs total
Distribution
Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA.
Product codes and lots
Lot #6118348 (5 pack), 6110170 (30 pack) and 6110210 (30 pack)