BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3170061 · Received May 15, 2013

    Report

    Report Number
    3003288808-2013-00253
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 16, 2013
    Manufacturer
    WAVELIGHT AG
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    SURGEON REPORTED, THAT A PT WHO UNDERWENT LASIK WAS NOTED TO HAVE UNEXPECTED REFRACTIVE OUTCOME. ADD'L INFO WAS RECEIVED, IN WHICH THE SURGEON DESCRIBED THE EVENT AS A 'REFRACTIVE SURPRISE'. REPORTER ALSO MENTIONED THAT THE POST-OP PACHYMETRY WAS OBSERVED TO BE LOWER THAN EXPECTED, ACCORDING TO THE PROGRAMMED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215972 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other TOBREX| TOPICAL ANESTHESIC