BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3760847 · Received April 4, 2014

    Report

    Report Number
    3003288808-2014-00606
    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) AT ONE DAY LASIK POST-OPERATIVE VISIT. ADDITION INFO INDICATED PT'S TOPICAL STEROID DOSAGE WAS INCREASED AND THE REPORTED EVENT HAD RESOLVED. THIS REPORT REFERENCES THE LEFT EYE. AN ADD'L REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203766 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INTRALASE