BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 376753 · Received February 7, 2002

    Report

    Report Number
    2028159-2002-00023
    Event Type
    Malfunction
    Date Received
    February 7, 2002
    Date of Event
    December 6, 2001
    Report Date
    December 10, 2001
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED SOMETHING LIKE WHITE POWDER IN EYE DURING PROCEDURE. ADDITIONAL INFORMTION RECEIVED ON 01/08/2002 INDICATED SUBSTANCE REMAINS IN EYE POST OPERATION. FELT THIS CAME FROM PROBE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 600DS OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 600DS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO