Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1706-2010

AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric...

Alcon Laboratories / initiated 2010-04-27 / Terminated / root cause: packaging

Ciba Vision Corporation began a recall of AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric lenses approved for daily wear and extended wear up... on . The reason FDA records is "The lenses inside the package do not match the prescription information for power labeled on the primary package". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1706-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. Toric lenses approved for daily wear and extended wear up to 6 nights.
Product code
LPM Lenses, Soft Contact, Extended Wear
Reason for recall
The lenses inside the package do not match the prescription information for power labeled on the primary package.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm. For further information, contact your CIBA Vision sales representative or call 1-877-542-5928.
Quantity in commerce
Lot #8717082, total 5040 lenses and Lot #8717066 total 5394 lenses
Distribution
Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI.
Product codes and lots
Lot Number: 8717082, Exp. 10/2013, Label Power: -0.50, Cylinder: -1.75, Axis: 180; and Lot Number: 8717066, Exp. 10/2013, Label Power: -2.50, Cylinder -1.75, Axis 180.