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Terminated

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.

FDA Recall Z-2012-2009 · Posted 2009-09-18

Recalling FirmVistakon
Recall StatusTerminated
Product CodeLPL
Date Initiated2009-04-20
Date Terminated2009-10-01
Product Quantity73

Reason for Recall

Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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