BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATARACT PACK

    MDR report key: 14778417 · Received June 22, 2022

    Report

    Report Number
    1423395-2022-00025
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 22, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY A BLUE FIBER WAS FOUND IN A PATIENT'S EYE DURING A PROCEDURE. THE SAMPLE HAS BEEN EVALUATED, HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND 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 FACILITY A BLUE FIBER WAS FOUND IN A PATIENT'S EYE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456031 CATARACT PACK OJK MEDLINE INDUSTRIES LP 22CBY945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention