Recall Z-0519-2021— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2020-11-07, terminated 2024-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Product may be missing toric axis marks..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-07
- Terminated
- 2024-07-11
- Firm location
- Clearwater, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.