BEUDAMED
    FDA Enforcement Class II Terminated

    Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.

    Recall: Z-2172-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2172-2017
    Event ID
    77170
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laserex Systems Inc.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    April 4, 2017
    Classification Date
    June 6, 2017
    Termination Date
    July 31, 2017
    Address
    7138 SHADY OAK RD, N/A, EDEN PRAIRIE, MN, 55344-3517, United States

    Description

    Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.

    Reason

    It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.

    Code Info

    Serial No: TR 0010, TR 0095

    Distribution

    US Distribution

    Quantity

    83