BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 3131095 · Received May 23, 2013

    Report

    Report Number
    3003288808-2013-00290
    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
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED THROUGH SOCIAL MEDIA THAT THEIR LASIK SURGERY "FAILED". REFRACTIVE MEASUREMENTS AND SOME HISTORY WERE PROVIDED; HOWEVER, NO CONTACT INFORMATION WAS PUBLISHED. THE PATIENT CANNOT BE IDENTIFIED, AND NO FURTHER FOLLOW UP IS POSSIBLE. THIS REPORT WILL ADDRESS THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227977 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention