BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETO WAVE EYE-Q

    MDR report key: 2960324 · Received February 8, 2013

    Report

    Report Number
    3003288808-2013-00036
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    October 30, 2012
    Report Date
    January 10, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 TECHNICIAN REPORTED THAT THREE AND A HALF MONTHS AFTER BILATERAL LASIK SURGERY, THE PT REPORTED THAT BOTH OF HER EYES FELT DRY. THE PT WAS UNABLE TO RETURN FOR FOLLOW UP EXAMS AND WILL BE SEEN BY ANOTHER DOCTOR CLOSER TO HER HOME. THIS REPORT CONCERNS THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54084 ALLEGRETO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other NONE REPORTED