BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2072406 · Received April 8, 2011

    Report

    Report Number
    3003288808-2011-00057
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    March 10, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    TECHNICIAN REPORTED LOSING ONE TREATMENT FROM WAVE CARD, AFTER HAVING RECEIVED A SYSTEM ENERGY ERROR MESSAGE DURING A SURGERY. ON FOLLOW UP COMMUNICATION, TECHNICIAN STATED THAT HIS REPORT WAS IN REGARDS TO A REQUEST TO RECEIVE CREDIT FOR THE LOST PROCEDURE ON WAVE CARD, AND NOT A COMPLAINT REGARDING THE LASER ERROR MESSAGE. TECHNICIAN STATED THAT THE SURGEON COMPLETED THE TREATMENT, AND THERE WERE NO PATIENT OUTCOME ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1