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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmApril 20, 2009
Date PostedSeptember 18, 2009
Recall Status1 Terminated 3 on October 01, 2009
Recall NumberZ-2012-2009
Recall Event ID 52828
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
ProductAcuvue 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.
FEI Number 1000222023
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
ActionFirm 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 Commerce73
DistributionNationwide.
Total Product Life CycleTPLC 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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