BEUDAMED
    FDA Enforcement Class II Terminated

    enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.

    Recall: Z-2552-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2552-2020
    Event ID
    85862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 22, 2020
    Initiation Date
    June 9, 2020
    Classification Date
    July 10, 2020
    Termination Date
    February 11, 2021
    Address
    21 N Park Place Blvd, N/A, Clearwater, FL, 33759-3917, United States

    Description

    enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.

    Reason

    The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

    Code Info

    Model number: MX60ET, Catalog number: MXUET Lot numbers: Lot Number 3043212 Serial Numbers: 3043212002 (UDI (01)10757770555199(17)230131(21)3043212002); 3043212005 (UDI (01)10757770555199(17)230131(21)3043212005); 3043212006 (UDI (01)10757770555199(17)230131(21)3043212006); 3043212007 (UDI (01)10757770555199(17)230131(21)3043212007); 3043212008 (UDI (01)10757770555199(17)230131(21)3043212008)

    Distribution

    U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.

    Quantity

    5