BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3770961 · Received December 19, 2013

    Report

    Report Number
    3003288808-2013-00859
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 30, 2013
    Report Date
    November 30, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    AN OPTOMETRIST REPORTED THAT A PATIENT WHO UNDERWENT BILATERAL LASIK WAS DIAGNOSED WITH ASYMPTOMATIC STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK) IN THE RIGHT EYE, AT THE ONE DAY POSTOPERATIVE VISIT. THE TOPICAL STEROID DROPS WERE INCREASED, AND THE DLK RESOLVED WITH TREATMENT. ANOTHER REPORT IS FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667712 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INTRALASE