Drug recall
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with…
FDA recall event 98402 · Class II · AMO Puerto Rico Manufacturing, Inc.
Key facts
| Event ID | 98402 |
|---|---|
| Recall numbers | Z-1634-2026 |
| Recalling firm | AMO Puerto Rico Manufacturing, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. |
| Initiation date | Feb 19, 2026 |
| Report date | Apr 1, 2026 |
| City | Anasco |
| State | PR |
| Country | United States |
| FEI number | 2648035 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: