BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTONSIGHT PROSE

    MDR report key: 18465698 · Received January 8, 2024

    Report

    Report Number
    3006204913-2024-00001
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    January 3, 2024
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON FOUNDATION FOR SIGHT
    Product Code
    HQD
    UDI-DI
    00785811435677
    PMA / PMN Number
    K183175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ·THE DEVICE IN QUESTION WAS MANUFACTURED ON 8/8/22 - 15 MONTHS OLD. ·THE DESIGN PROFILE FOR THE LENS WAS REVIEWED. THE THICKNESS WAS ADEQUATE AND PER SPECIFICATION, AND THE DESIGNS WERE STABLE ·THE FIT CONNECT WORK ORDER AND PROCESS CONTROL LOG WERE REVIEWED - THE THICKNESS WAS ADEQUATE AND PER SPECIFICATION, AND THE DESIGN WAS STABLE. THE DEVICE WAS MANUFACTURED CORRECTLY AND WITHIN ALL SPECIFIED TOLERANCES ·NO OTHER COMPLAINTS HAVE BEEN LOGGED FOR THIS SPECIFIC B&L MATERIAL LOT NUMBER ·A REVIEW OF THE NONCONFORMING MATERIALS REPORTS SHOWS NO NCR'S LOGGED FOR THIS SPECIFIC MATERIAL LOT NUMBER ·THE B&L CERTIFICATE OF ANALYSIS AND INCOMING INSPECTION REPORTS FOR THE LOT WERE REVIEWED - NO ISSUES WITH THE MATERIAL.

    Description of Event or Problem · 0

    DEVICE BROKE WHILE IN PATIENTS EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568864 BOSTONSIGHT PROSE BOSTONSIGHT PROSE HQD BOSTON FOUNDATION FOR SIGHT N/A 21363007 00785811435677

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Other