Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1634-2026 — 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,controlle

U.S. FDA — Device Enforcement · United States · 2026-02-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1634-2026
Date of alert: 2026-02-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AMO Puerto Rico Manufacturing, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05050474731776

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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