BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1670-2013 · Initiated May 23, 2013

    Recall

    Recall Number
    Z-1670-2013
    Event Number
    65292
    Firm
    Abbott Medical Optics, Inc.
    FEI Number
    3006695864
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 23, 2013
    Posted
    July 9, 2013
    Terminated
    October 6, 2014
    Address
    510 Cottonwood Dr, Milpitas, CA, 95035-7403

    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.

    Action

    AMO issued an "Urgent Notice of Medical Device Correction and Advisory Notice" on May 23, 2013 via email, to all customers with a Sovereign Compact Phacoemulsification System v 5.3 to inform them of the issue and provide them with actions to take in the event of sound loss during use of the Sovereign Compact Phacoemulsification System, v 5.3.

    Distribution

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

    Quantity

    534 systems