BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3142975 · Received May 30, 2013

    Report

    Report Number
    3003288808-2013-00311
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 2, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A LASER CENTER DIRECTOR REPORTED THAT A PATIENT WHO UNDERWENT BILATERAL LASIK WAS BELIEVED TO BE NOT HEALING AS EXPECTED; THE PATIENT STILL HAD ASTIGMATISM AT (B)(6) WEEKS POST SURGERY. THE PATIENT'S LAST VISIT WAS (B)(6) 2013 AND THE ASTIGMATISM WAS NOTED AT THAT TIME; HOWEVER UPON REVIEWING THE CHART ON (B)(6) 2013, IT WAS DETERMINED BY THE LASER CENTER THAT THE EVENT WOULD BE REPORTED TO THE MANUFACTURER. THE PATIENT HAD DISCONTINUED HER DROPS PER THE NORMAL POST-OP ROUTINE, BY THE TIME SHE WAS SEEN ON (B)(6) 2013, AND CURRENTLY REMAINS ON NO DROPS. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP EXAM IN (B)(6), BUT DID NOT KEEP THAT APPOINTMENT. THE PATIENT HAS RESCHEDULED THE FOLLOW UP APPOINTMENT TO (B)(6). THIS REPORT WILL ADDRESS THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238087 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other INTRALASE