Intraocular Lens Recall: TECNIS Eyhance IOL with Simplicity DS
Announced 2026-04-01 · FDA
The FDA is recalling 361 units of TECNIS Eyhance IOL with TECNIS Simplicity Delivery System (model DIB00) distributed nationwide in CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, and WI, due to a haptic that may stick to the optic and prevent unfolding as expected. The recall is moderate in severity and lists specific lot/serial numbers.
| Brand | AMO Puerto Rico Manufacturing, Inc. |
|---|---|
| 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 | 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. |
| Severity | moderate |
| Units affected | 361 |
| Distribution | U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403 |
WHAT YOU SHOULD DO
- Check if your eye implant is part of the recall by consulting your surgeon and reviewing the recall list of lot/serial numbers.
- Contact your eye care professional or hospital to discuss next steps and potential monitoring or replacement options.
- If you notice vision changes or other symptoms, seek prompt medical attention.
- Do not attempt to modify or replace the implanted device yourself.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.