BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3760848 · Received April 4, 2014

    Report

    Report Number
    3003288808-2014-00607
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 9, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PT WITH DIFFUSE LAMELLAR KERATITIS (DLK) OF THE RIGHT EYE AT ONE DAY LASIK POST-OPERATIVE VISIT. ADDITION INFO INDICATED PT'S TOPICAL STEROID DOSAGE WAS INCREASED AND THE REPORTED EVENT HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203699 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention INTRALASE