BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 176734 · Received July 9, 1998

    Report

    Report Number
    2028159-1998-00195
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    June 10, 1998
    Report Date
    June 11, 1998
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED PHACO TIP WOULDN'T WORK (NO "U/S" POWER). REMOVED HANDPIECE FROM EYE TO TIGHTEN TIP. REINSERTED AND CREATED CORNEAL BURN. SUTURED WOUND TO CLOSE. CONTINUED TO USE SYSTEM IN FOLLOWING CASES WITHOUT INCIDENT. WANTED HANDPIECE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON LABORATORIES, INC STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention