BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 754528 · Received October 20, 2005

    Report

    Report Number
    2028159-2005-00177
    Event Type
    Malfunction
    Date Received
    October 20, 2005
    Date of Event
    September 15, 2005
    Report Date
    September 19, 2005
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.10: SYSTEM WAS USED BY ANOTHER SURGEON WITHOUT PROBLEM.

    Description of Event or Problem · 1

    REPORTER NOTED CORNEAL BURN TOOK PLACE WITHIN FIRST 10 SECS OF OS PHACO PROCEDURE. NO INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO