BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3770981 · Received December 18, 2013

    Report

    Report Number
    3003288808-2013-00840
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 23, 2013
    Report Date
    November 26, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PATIENT WITH FLAP STRIAE FOR THE LEFT EYE, AT LASIK POST-OPERATIVE VISIT. ADDITIONAL INFORMATION INDICATED A FLAP LIFT AND RINSE WAS PERFORMED. AN ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664096 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INTRALASE