BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 296429 · Received September 15, 2000

    Report

    Report Number
    2028159-2000-00233
    Event Type
    Malfunction
    Date Received
    September 15, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 18, 2000
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED CORNEAL BURN OCCURRED DURING PROCEDURE. NO INTERVENTION REPORTED. FELT TIP WAS GETTING HOT; POSSIBLY DUE TO WRONG SETTINGS FOR TIP STYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO