BEUDAMED
    FDA Enforcement Class II Terminated

    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

    Recall: Z-2202-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2202-2013
    Event ID
    66027
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sonogage Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 9, 2013
    Classification Date
    September 16, 2013
    Termination Date
    September 19, 2015
    Address
    26650 Renaissance Pkwy, N/A, Cleveland, OH, 44128-5776, United States

    Description

    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

    Reason

    During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.

    Code Info

    Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.

    Distribution

    Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.

    Quantity

    564 units