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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm April 20, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on October 01, 2009
Recall Number Z-2012-2009
Recall Event ID 52828
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product Acuvue Advance for Astigmatism Diagnostic Product.
Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07.
Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12.

Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.
Code Information B007NV51 and B0077KM1.
Recalling Firm/
Manufacturer		 Vistakon
7500 Centurion Pkwy Ste 100
Jacksonville FL 32256-0517
For Additional Information Contact
904-443-1763
Manufacturer Reason
for Recall		 Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.
FDA Determined
Cause 2		 Other
Action Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.
Quantity in Commerce 73
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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