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TECNIS Eyhance IOL with Simplicity Delivery System
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MEDICAL DEVICE RECALLMODERATE

TECNIS Eyhance IOL with Simplicity Delivery System

AMO is recalling TECNIS Eyhance IOLs with Simplicity Delivery Systems because the lens haptic may stick, preventing proper unfolding.

What to do

Healthcare providers should immediately stop using the affected delivery systems and return them to the manufacturer. Contact your surgical representative or the firm for further instructions regarding product returns and replacements.

Posted
Updated
Recall No.
Z-1634-2026
Agency
Firm
AMO Puerto Rico Manufacturing, Inc.
Recall ID
98402
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 05050474731776 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification