Recall database

Intraocular Lens recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-1634-2026

AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: T…

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.

AMO Puerto Rico Manufa…PRApr 1, 2026

Class IIIOngoingZ-2451-2025

Bausch & Lomb Surgical, Inc. recalls Akreos

An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acui…

Bausch & Lomb Surgical…FLSep 3, 2025

Class IOngoingZ-1679-2025

Bausch & Lomb Surgical, Inc. recalls Intraocular lens. enVista Monofocal IOL

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

Bausch & Lomb Surgical…FLMay 14, 2025