Recall Z-2012-2009 ยท LPL Lenses, Soft Contact, Daily Wear
Vistakon
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.
| Date | Sep 18, 2009 (initiated Apr 20, 2009) |
| Status | Terminated |
| Reason | Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling. |
| 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 | 73 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.