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U.S. Department of Health and Human Services

Class 2 Device Recall AIR OPTIX

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 Class 2 Recall
AIR OPTIX
see related information
Date Posted May 27, 2010
Recall Status1 Terminated on October 22, 2010
Recall Number Z-1706-2010
Recall Event ID 55570
Premarket Approval
PMA Number
P010019/S011
Product Classification Lenses, Soft Contact, Extended Wear - Product Code LPM
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.
Code Information 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.
Recalling Firm/
Manufacturer
Ciba Vision Corporation
11460 Johns Creek Pkwy
Duluth, Georgia 30097
Consumer Instructions No consumer action necessary
For Additional Information Contact Joseph (Skip) Burke
678-415-3350
Manufacturer Reason
for Recall
The lenses inside the package do not match the prescription information for power labeled on the primary package.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPM and Applicant = CIBA VISION CORPORATION
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