BEUDAMED
    FDA Enforcement Class II Terminated

    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

    Recall: Z-1670-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1670-2013
    Event ID
    65292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical Optics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 17, 2013
    Initiation Date
    May 23, 2013
    Classification Date
    July 9, 2013
    Termination Date
    October 6, 2014
    Address
    510 Cottonwood Dr, N/A, Milpitas, CA, 95035-7403, United States

    Description

    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

    Reason

    Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign¿ Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.

    Code Info

    Product Name: Sovereign¿ Compact Console Universal, Part Number: CMP680300. The Sovereign¿ Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign¿ Compact systems manufactured at the Third Party Manufacturer, Sanmina-SCI Corporation, the serial number format is YYYY35XXX where Y is for the year manufactured and "35" designates manufacturing at Sanmina-SCI Corporation. The Sanmina-SCI Corporation started manufacturing the Sovereign¿ Compact v 5.3 systems in February 2012. For Sovereign¿ Compact systems manufactured at the AMO Manufacturing USA, LLC facility in Milpitas, CA the serial number format is YYYY80XXX where Y is for the year manufactured and "80" designates manufacturing at Milpitas. The Milpitas facility started manufacturing the v 5.3 systems in February 2013. The serial number is contained in the Product Identification Label (part number Z352548) that is attached to the rear of the console for systems manufactured.

    Distribution

    Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.

    Quantity

    534 systems