BEUDAMED
    FDA Enforcement Class II Ongoing

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    Recall: Z-2097-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2097-2021
    Event ID
    88146
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dutch Ophthalmic USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 28, 2021
    Initiation Date
    April 14, 2021
    Classification Date
    July 19, 2021
    Address
    10 Continental Dr Bldg 1, N/A, Exeter, NH, 03833-7507, United States

    Description

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    Reason

    Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

    Code Info

    Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

    Distribution

    Nationwide Distribution in the states of CA, FL, MA, and UT.

    Quantity

    13 Boxes