BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0519-2021 · Initiated November 7, 2020

    Recall

    Recall Number
    Z-0519-2021
    Event Number
    86721
    Firm
    Bausch & Lomb Surgical, Inc.
    FEI Number
    1119279
    Product Code
    MJP
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    November 7, 2020
    Terminated
    July 11, 2024
    Address
    21 N Park Place Blvd, Clearwater, FL, 33759-3917

    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

    Product may be missing toric axis marks.

    Action

    The firm initiated the recall by letter on 11/07/2020. The letter requested the consignee review their inventory and quarantine all suspect product. It further requested that the consignee complete the acknowledgement form and contact Bausch & Lomb to obtain a Return Material Authorization Number and arrange for pick up of the devices. Those with questions or concerns regarding the process should call 1-800-338-2020.

    Distribution

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

    Quantity

    31 devices