BEUDAMED
    FDA Enforcement Class II Terminated

    EyeBOX Model OCL 02

    Recall: Z-2398-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2398-2019
    Event ID
    82922
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OCULOGICA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 4, 2019
    Initiation Date
    April 16, 2019
    Classification Date
    August 27, 2019
    Termination Date
    April 10, 2020
    Address
    33 Irving Pl, N/A, New York, NY, 10003-2332, United States

    Description

    EyeBOX Model OCL 02

    Reason

    A review of the user manual revealed that two precaution statements were missing.

    Code Info

    Serial Numbers TT003, TT004, TT005

    Distribution

    The products were distributed to the following US states: MD and NY

    Quantity

    3