Device recall
Z-0779-2018: Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a…
FDA device recall · Class II · Alcon Research, LTD.
Key facts
| Recall number (Z-number) | Z-0779-2018 |
|---|---|
| Recall event | 79226 |
| Product | Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. |
| Product code | HQC |
| Recalling firm | Alcon Research, LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2022 |
| 510(k) numbers | K101285 |
| FEI number | 1000117501 |
At a glance
- 1–9 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