BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3093801 · Received April 30, 2013

    Report

    Report Number
    3003288808-2013-00202
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT OVER THE PAST THREE WEEKS, THERE HAVE BEEN ONE DOZEN OR MORE PTS THAT WERE OVERCORRECTED. HE BELIEVES THAT IT IS LIKELY THAT THEY WILL NEED ENHANCEMENTS. HE ALSO STATED THAT NORMALLY HE GETS EXCELLENT RESULTS WITH THE USE OF HIS NOMOGRAM. THE SURGEON AGREED TO PROVIDE PT AND TREATMENT DETAILS, AND AGREED TO COMPLETE A QUESTIONNAIRE FOR EACH PT; HOWEVER, THE QUESTIONNAIRES HAVE NOT BEEN RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186939 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other