BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 3131094 · Received May 23, 2013

    Report

    Report Number
    3003288808-2013-00289
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 24, 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
    IT
    Reporter Occupation
    UNKNOWN

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A PT REPORTED THROUGH SOCIAL MEDIA THAT THEIR LASIK SURGERY "FAILED". REFRACTIVE MEASUREMENTS AND SOME HISTORY WERE PROVIDED; HOWEVER, NO CONTACT INFO WAS PUBLISHED. THE PT CANNOT BE IDENTIFIED, AND NO FURTHER F/U IS POSSIBLE. THIS REPORT WILL ADDRESS THE PT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229505 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention