BEUDAMED
    FDA Enforcement Class II Ongoing

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    Recall: Z-1971-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1971-2023
    Event ID
    92532
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ellex Medical Pty Ltd.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    July 5, 2023
    Initiation Date
    March 16, 2023
    Classification Date
    June 27, 2023
    Address
    3-4 Second Ave, N/A, Mawson Lakes, N/A, N/A, Australia

    Description

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    Reason

    When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

    Code Info

    Serial Nos., UDI IPY0374, (01) 0 9342395 00012 0 ISRY0242, (01) 0 9342395 00015 1 ISG0370, (01) 0 9342395 00024 3 IPG0539, (01) 0 9342395 00009 0 BG1190

    Distribution

    US nationwide/ Worldwide Distribution

    Quantity

    57 systems in total (6 units shipped to United States)