FDA recall Z-0519-2021

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 for recall

Product may be missing toric axis marks.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-07

Report date

2020-12-09

Termination date

2024-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clearwater, FL, United States

Primary source

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