Device recall
Z-0187-2019: CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #…
FDA device recall · Class I · Alcon Research, LTD.
Key facts
| Recall number (Z-number) | Z-0187-2019 |
|---|---|
| Recall event | 80931 |
| Product | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use. |
| Product code | OGO |
| Recalling firm | Alcon Research, LTD. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 18, 2020 |
| PMA numbers | P150037 |
| FEI number | 2523835 |
At a glance
- None 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