MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Produ...

FDA Device Recall #Z-0519-2021 — Class II — November 7, 2020

Recall Summary

Recall Number Z-0519-2021
Classification Class II — Moderate risk
Date Initiated November 7, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bausch & Lomb Surgical, Inc.
Location Clearwater, FL
Product Type Devices
Quantity 31 devices

Product Description

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

Reason for Recall

Product may be missing toric axis marks.

Distribution Pattern

US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.

Lot / Code Information

Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005 3043816006 3043816007 3043816008 3043816009 3043816010 3043816011 3043816012 3043816013 3043816014 3043816015 3043816016 3043816017 3043816018 3043816019 3043816020 3043816023 3043816024 3043816025 3043816026 3043816027 3043816028 3043816029 3043816030 3043816031

Other Recalls from Bausch & Lomb Surgical, Inc.

Recall # Classification Product Date
Z-2451-2025 Class III Akreos, SKU: AO60P0300. Akreos intraocular lenses Jun 6, 2025
Z-1680-2025 Class I Intraocular Lens. enVista Envy IOL, All models ... Mar 27, 2025
Z-1679-2025 Class I Intraocular lens. enVista Monofocal IOL, All mo... Mar 27, 2025
Z-2552-2020 Class II enVista one-piece hydrophobic acrylic toric int... Jun 9, 2020
Z-0628-2019 Class II enVista One Piece Hydrophobic Acrylic Intraocul... Nov 5, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.