BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3760870 · Received April 4, 2014

    Report

    Report Number
    3003288808-2014-00610
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 8, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A BILATERAL CASE OF TRACE DIFFUSE LAMELLAR KERATITIS (DLK) AND LIGHT SENSITIVITY, OBSERVED AT ONE DAY POST LASIK TREATMENT. RPTR INDICATED THE PT WAS PLACE ON AN INCREASED TOPICAL STEROID DOSAGE. PT NOTED LIGHT SENSITIVITY WAS MILD. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS PT. THIS REPORT ADDRESSES THE LEFT EYE, AND ANOTHER MFR REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203769 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