Device recall
Z-2441-2008: MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in…
FDA device recall · Class II · Alcon Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-2441-2008 |
|---|---|
| Recall event | 49113 |
| Product | MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract… |
| Product code | KYB |
| Recalling firm | Alcon Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 26, 2009 |
| 510(k) numbers | K001157 |
| FEI number | 1610287 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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