BEUDAMED
    FDA Enforcement Class II Terminated

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    Recall: Z-2411-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2411-2012
    Event ID
    63011
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haag-Streit USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 26, 2012
    Initiation Date
    August 17, 2012
    Classification Date
    September 20, 2012
    Termination Date
    May 29, 2015
    Address
    3535 Kings Mills Rd, Mason, OH, 45040, United States

    Description

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    Reason

    The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

    Code Info

    Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.

    Quantity

    64 units