BEUDAMED
    FDA Enforcement Class II Terminated

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    Recall: Z-1597-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1597-2016
    Event ID
    73767
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    October 6, 2014
    Classification Date
    May 3, 2016
    Termination Date
    March 31, 2017
    Address
    6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    Reason

    The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

    Code Info

    Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H

    Distribution

    Nationwide Distribution.

    Quantity

    6597 packs