BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR PLASTIC EYESHIELD

    MDR report key: 21677626 · Received March 24, 2025

    Report

    Report Number
    MW5168024
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 18, 2025
    Manufacturer
    7051395 CANADA INC DBA HTA DIRECT SOURCING
    Product Code
    HOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON POSTOP VISIT SURGEON NOTICED A RED FIBER UNDER THE CATARACT LENS OF PATIENT. HAD TO BRING PATIENT BACK TO OR FOR REMOVAL ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718866 CLEAR PLASTIC EYESHIELD SHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC HOY 7051395 CANADA INC DBA HTA DIRECT SOURCING 20210120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention