MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Reported: December 9, 2020 Initiated: November 7, 2020 #Z-0519-2021
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.
Details
- Recalling Firm
- Bausch & Lomb Surgical, Inc.
- Units Affected
- 31 devices
- Distribution
- US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 31 devices.
Why was this product recalled? ▼
Product may be missing toric axis marks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0519-2021.
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