Device recall
Z-0028-2022: TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation…
FDA device recall · Class II · Johnson & Johnson Surgical Vision Inc
Key facts
| Recall number (Z-number) | Z-0028-2022 |
|---|---|
| Recall event | 88564 |
| Product | TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system… |
| Product code | MJP |
| Recalling firm | Johnson & Johnson Surgical Vision Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 6, 2023 |
| PMA numbers | P980040, P980040S117 |
| FEI number | 3003843509 |
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