BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2063795 · Received April 15, 2011

    Report

    Report Number
    3003288808-2011-00072
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    SURGEON REPORTED TREATMENT WAS INTERRUPTED BY SCANNER ERROR MESSAGE. SURGEON REPROGRAMMED THE SYSTEM FOR A SECOND TREATMENT, TO COMPLETE CASE. POST OP INFO PROVIDED REFLECTED AN UNDERCORRECTION. ON F/U COMMUNICATION, IT WAS LEARNED THAT THE CASE WAS RETREATED TWENTY DAYS AFTER THE FIRST SURGERY. POST OPERATIVE UNCORRECTED VISION, ONE DAY AFTER RETREATMENT, WAS STATED TO BE 20/20.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention