Device recall
Z-1634-2026: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product…
FDA device recall · Class II · AMO Puerto Rico Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-1634-2026 |
|---|---|
| Recall event | 98402 |
| Product | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled… |
| Product code | HQL |
| Recalling firm | AMO Puerto Rico Manufacturing, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P980040, P980040S117 |
| FEI number | 2648035 |
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