BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1791496 · Received August 6, 2010

    Report

    Report Number
    3003288808-2010-00405
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INVOLVED" (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): "CARD READ ISSUE" (COMPUTER SOFTWARE ISSUE). TECHNICIAN REPORTED WAVE CARD DID NOT WORK. WAVE CARD WAS RETURNED TO ALCON CUSTOMER SERVICE, FOR CREDIT AND REPLACEMENT. WAVE CARD SHOWED ZERO PROCEDURE ON FIRST TEST, AND SHOWED 'CAN'T READ CHIP, FUSES ON' AT SECOND TEST, WHEN RETURNED CARD WAS TESTED BY ALCON CUSTOMER SERVICE. ALCON TECHNICAL SUPPORT WAS CONTACTED, AND THEY STATED THAT CARD USE NOT FOUND ON THE SYSTEM LOG FILE. CURRENT INFORMATION DOES NOT INDICATE PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG (PRESSATH) 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA