BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4102176 · Received September 17, 2014

    Report

    Report Number
    3003288808-2014-01408
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 19, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P0300008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE CRITERIA. 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

    A SURGICAL COORDINATOR REPORTED TRACKING ISSUES DURING PROCEDURES. REPORTER INDICATED THERE WERE NO UNEXPECTED POST-OPERATIVE RESULTS AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576929 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1