BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3142962 · Received May 30, 2013

    Report

    Report Number
    3003288808-2013-00310
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING LASIK PROCEDURE, LASER LOCKED UP MIDWAY THROUGH TREATMENT AND READ TREATMENT COMPLETE. LOGFILE SHOWED THAT THE PUPIL WAS NOT DETECTED, BUT THE SURGEON MENTIONED THAT THE TRACKER IMAGE WAS GOOD. PROCEDURE WAS NOT COMPLETED AND DURING F/U WITH THE REPORTER, IT WAS NOTED THAT THE PT RETURNED IN ONE WEEK FOR RETIREMENT. PT OUTCOME WAS NOTED TO HAVE BEEN RESOLVED WITH ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238472 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention BIRTH CONTROL PILLS