BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3122223 · Received May 17, 2013

    Report

    Report Number
    3003288808-2013-00265
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    WAVELIGHT AG
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENT 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

    AN OPTOMETRIST REPORTED THAT A PATIENT WHO UNDERWENT BILATERAL LASIK WAS DIAGNOSED WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK), AT INFERIOR FLAP EDGE ON THE LEFT EYE, AT THE ONE DAY POST-OP VISIT. PATIENT WAS REPORTED TO HAVE BEEN TREATED WITH STEROID DROPS. REPORTER ALSO NOTED PATIENT EXPRESSING IRRITATION IN BOTH EYES, AT THE TIME OF EVENT. UPON FOLLOW UP, REPORTER INFORMED THAT THE DLK RESOLVED WITH TREATMENT. THIS REPORT WILL FOLLOW THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218828 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INTRALASE