Device recall
Z-2012-2009: Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package…
FDA device recall · Class III · Vistakon
Key facts
| Recall number (Z-number) | Z-2012-2009 |
|---|---|
| Recall event | 52828 |
| 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 code | LPL |
| Recalling firm | Vistakon |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 1, 2009 |
| FEI number | 1000222023 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database