BEUDAMED
    FDA Enforcement Class III Terminated

    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

    Recall: Z-1441-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1441-2013
    Event ID
    65191
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Optovue, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 14, 2013
    Classification Date
    May 31, 2013
    Termination Date
    October 24, 2013
    Address
    2800 Bayview Dr, N/A, Fremont, CA, 94538-6518, United States

    Description

    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

    Reason

    Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.

    Code Info

    iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.

    Distribution

    Distributed Nationwide and in Canada.

    Quantity

    ~329 users