BEUDAMED
    FDA Recall 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 · Initiated April 4, 2017

    Recall

    Recall Number
    Z-2172-2017
    Event Number
    77170
    Firm
    Laserex Systems Inc.
    FEI Number
    1000520094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 4, 2017
    Posted
    June 6, 2017
    Terminated
    July 31, 2017
    Address
    7138 SHADY OAK RD, EDEN PRAIRIE, MN, 55344-3517

    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.

    Action

    Ellex Medical shall, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard. 1. Installation of a spacer/collar to prevent the slit lamp from being lowered to the point where the cable can be crushed, 2. Improvement of cable management, 3. The corrections will be conducted at no cost to the purchaser, and 4. The corrective action will be completed by June 30, 2017. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (800) 824-7444.

    Distribution

    US Distribution

    Quantity

    83