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

MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag. — recall Z-0519-2021

U.S. FDA — Device Enforcement · United States · 2020-11-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0519-2021
Date of alert
2020-11-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bausch & Lomb Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3043816001
Reported risk: Product may be missing toric axis marks.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.