Medical Device Recall: 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 Pr
AMO Puerto Rico Manufacturing, Inc. · February 19, 2026
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.
Product Description
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
Distribution
U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
States Affected
NATIONWIDE
Quantity Affected
361
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1634-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.