FDA DeviceClass IINotable

FDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance

Name: FDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance
Brand: AMO Puerto Rico Manufacturing, Inc.

Date: 2026-04-01

Brand: AMO Puerto Rico Manufacturing, Inc.

Category: Medical Device

FDA Class: Class II

Description

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.

Hazard

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.