BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3180198 · Received June 13, 2013

    Report

    Report Number
    3003288808-2013-00340
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT HAD BEEN PREPARED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) AND WAS POSITIONED UNDER THE LASER. AFTER THE EPITHELIUM HAD BEEN REMOVED, IT WAS DETERMINED THAT THE LASER WOULD NOT TRACK THE PUPIL. A BANDAGE CONTACT LENS WAS INSERTED AND THE PT WAS SENT HOME. THE SURGEON DID NOT PROVIDE THE STAFF WITH DEFINITIVE INFO REGARDING WHAT THE F/U WOULD BE, OR IF THEY MIGHT TRY AGAIN TO TREAT THE PT. THE REPORTER DECLINED TO PROVIDE PT IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270109 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK