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

FDA device recall Z-1706-2010 · posted 2010-05-27 · Terminated

Recall details

Recalling firm
Ciba Vision Corporation
Reason for recall
The lenses inside the package do not match the prescription information for power labeled on the primary package.
Action taken
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.
Root cause
Packaging process control
Status
Terminated
Product code
LPM
Quantity affected
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.
Date initiated
2010-04-27
Date posted
2010-05-27
Date terminated
2010-10-22
Location
Duluth, GA

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