BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3042182 · Received April 4, 2013

    Report

    Report Number
    3003288808-2013-00155
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    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

    A SURGEON REPORTED 20 LASIK RETREATMENTS ON EYES DUE TO THE FACT THAT THIS SURGIVISION DATA LINK ACCESS WAS CUT-OFF IMMEDIATELY. THE SURGEON REPORTED PATIENTS WERE RETREATED AND ARE SATISFIED AND ARE NOT COMPLAINING OF ON-GOING ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138167 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGIVISION DATALINK NOMOGRAM