BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3122225 · Received May 17, 2013

    Report

    Report Number
    3003288808-2013-00263
    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 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

    AN OPTOMETRIST REPORTED A CASE OF TRACE DIFFUSE LAMELLAR KERATITIS (DLK), AT NASAL FLAP EDGE OF ONE RIGHT EYE OF A PATIENT, ONE DAY POST BILATERAL LASIK PROCEDURE. PATIENT WAS REPORTED TO HAVE BEEN TREATED WITH TOPICAL STEROID DROPS. UPON FOLLOW UP, REPORTER INFORMED THAT THE DLK RESOLVED AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218989 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INTRALASE