Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery… — Class II medical device recall Z-1634-2026
Ongoing recall by AMO Puerto Rico Manufacturing, Inc., reported 2026-04-01, distributed nationwide. Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic wh
| Recall number | Z-1634-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMO Puerto Rico Manufacturing, Inc., Anasco, PR, United States |
| Recall initiated | 2026-02-19 |
| Classified | 2026-03-24 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 361 |
| UPC / GTIN / UDI-DI | 05050474731776 |
| Serial numbers | 2409342403, 2409612403, 2409692403, 2409752403, 2410072403, 2530842403, 2531212403, 2531242403, 2531622403, 2531882403, 2531892403, 2531902403, 2891132403, 2891682403, 2892032403 |
| Model numbers | DIB00 |
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 and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1634-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.