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.
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