Z-0519-2021 Class II Terminated
FDA device recall Z-0519-2021 was initiated by Bausch & Lomb Surgical, Inc. on November 7, 2020 and is designated Class II. Reason for recall: Product may be missing toric axis marks. The recall status is terminated (terminated July 11, 2024). Affected quantity: 31 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- November 7, 2020
- Termination Date
- July 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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