BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3093803 · Received April 30, 2013

    Report

    Report Number
    3003288808-2013-00200
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    AN OPTOMETRIST REPORTED THAT A PT WAS DIAGNOSED WITH TRACE DLK IN THE LEFT EYE, ONE DAY POST BILATERAL LASIK. THE STEROID DROPS WERE INCREASED TO EVERY HOUR DURING THE FIRST DAY, THEN DECREASED TO EVERY TWO HOURS, AND THEN FOUR TIMES A DAY. THE PT WAS LAST SEEN ON (B)(6) 2013. THE STEROID DROPS HAVE BEEN DISCONTINUED AND THE DLK HAS CLEARED. THE UCVA IS UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187552 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention INTRALASE