BEUDAMED
    FDA Recall Terminated

    EyeBOX Model OCL 02

    Recall: Z-2398-2019 · Initiated April 16, 2019

    Recall

    Recall Number
    Z-2398-2019
    Event Number
    82922
    Firm
    OCULOGICA
    FEI Number
    3014535677
    Product Code
    QEA
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 16, 2019
    Terminated
    April 10, 2020
    Address
    33 Irving Pl, New York, NY, 10003-2332

    Description

    EyeBOX Model OCL 02

    Reason

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

    Action

    IMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19.

    Distribution

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

    Quantity

    3