Z-2012-2009

Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl...

Name: Z-2012-2009 Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl...
Creator: Vistakon
Published: 2009-04-20
License: https://open.fda.gov/license/

Johnson & Johnson Vision Care, Inc. / initiated 2009-04-20 / Terminated / root cause: labeling and UDI

FDA source

Vistakon began a recall of Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package... on 2009-04-20. The reason FDA records is "Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2012-2009
Status: Terminated
Initiated: 2009-04-20
Posted: 2009-09-18
Terminated: 2009-10-01
Recalling firm: Johnson & Johnson Vision Care, Inc.
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: B007NV51 and B0077KM1.

Product code LPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)