BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SURGERY CENTER CATARACT

    MDR report key: 19288744 · Received May 10, 2024

    Report

    Report Number
    1423395-2024-00412
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 10, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OJK
    UDI-DI
    40195327250417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "MOXIFLOXACIN IS PLACED IN A MED CUP FROM THE PACK AND DRAWING UP IN A TB SYRINGE FROM THE PACK. A STERILE DISPOSABLE CANNULA IS PUT ON THE SYRINGE AND THE MOXI IS INJECTED INTRACAMERALLY. ONCE DELIVERED FIBERS CAN BE SEEN FLOATING IN THE EYE. MOXI IS THEN FLUSHED OUT OF THE EYE AND ANOTHER DOSE IS PLACED UNTIL NO FIBERS ARE SEEN". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "MOXIFLOXACIN IS PLACED IN A MED CUP FROM THE PACK AND DRAWING UP IN A TB SYRINGE FROM THE PACK. A STERILE DISPOSABLE CANNULA IS PUT ON THE SYRINGE AND THE MOXI IS INJECTED INTRACAMERALLY. ONCE DELIVERED FIBERS CAN BE SEEN FLOATING IN THE EYE. MOXI IS THEN FLUSHED OUT OF THE EYE AND ANOTHER DOSE IS PLACED UNTIL NO FIBERS ARE SEEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535230 THE SURGERY CENTER CATARACT OJK MEDLINE INDUSTRIES, LP 24ABN973 40195327250417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other