BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800 CS

    MDR report key: 731657 · Received June 24, 2006

    Report

    Report Number
    2028159-2006-00202
    Event Type
    Malfunction
    Date Received
    June 24, 2006
    Report Date
    May 24, 2006
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H-10 ; A CO SERVICE REP CHECKED SYSTEM; FOUND IT MET PERFORMANCE SPECIFICATIONS. THE REPORT MAILED IN TO THE FDA ON: 06/24/2006.

    Description of Event or Problem · 1

    REPORTER NOTED PHACO BURN OCCURRED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800 CS OPHTHALMIC SURGERY SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER ACCURUS 800CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO