BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTONSIGHT PROSE

    MDR report key: 22896332 · Received August 26, 2025

    Report

    Report Number
    3006204913-2025-00001
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 14, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BOSTON FOUNDATION FOR SIGHT
    Product Code
    HQD
    UDI-DI
    00785811435639
    PMA / PMN Number
    K183175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DESIGN PROFILE FOR THE LENS WAS REVIEWED. THE THICKNESS WAS ADEQUATE AND PER SPECIFICATION, AND THE DESIGNS WERE STABLE. THE FITCONNECT 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

    PATIENT STATES THAT UPON REMOVAL OF THE DEVICE HER EYE SWELLED AND BECAME RED. PT. REPORTED PAIN AND BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866494 BOSTONSIGHT PROSE BOSTONSIGHT PROSE HQD BOSTON FOUNDATION FOR SIGHT N/A 20030007 00785811435639

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention