Recall Z-1634-2026— AMO Puerto Rico Manufacturing, Inc.

Class II FDA medical device recall by AMO Puerto Rico Manufacturing, Inc., initiated 2026-02-19. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

AMO Puerto Rico Manufacturing, Inc.

Classification

Class II

Status

Ongoing

Initiated

2026-02-19

Firm location

Anasco, PR, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.