FDA DeviceClass IINotable

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

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.

Remedy

361

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