FDA-Device2020-12-09Class II

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

Bausch & Lomb Surgical, Inc.
Hazard

Product may be missing toric axis marks.

Sold states
US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
Affected count
31 devices
Manufactured in
21 N Park Place Blvd, N/A, Clearwater, FL, United States
Products
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0519-2021

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