BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRO TOPOLYZER VARIO

    MDR report key: 6973768 · Received October 24, 2017

    Report

    Report Number
    3003288808-2017-02289
    Event Type
    Injury
    Date Received
    October 24, 2017
    Report Date
    February 14, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MMQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED ONE DIOPTER OF OVER CORRECTION THREE WEEKS FOLLOWING TOPOGRAPHY GUIDED LASIK TREATMENT. ADDITIONAL INFORMATION PROVIDED, INCONSISTENT DATA WAS SENT TO THE LASER FROM THE IMAGING SYSTEM WHICH WAS SUBSEQUENTLY CONFIRMED AS A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751010 ALLEGRO TOPOLYZER VARIO TOPOGRAPHER, CORNEAL, AC-POWERED MMQ WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other