BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO TOPOLYZER VARIO

    MDR report key: 2854755 · Received November 30, 2012

    Report

    Report Number
    3003288808-2012-00494
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MMQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 ACCORDING WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE MEASUREMENTS OF ONE PT WERE ASSOCIATED WITH THE NAME OF ANOTHER PT. THE MEASUREMENTS WERE NOT USED TO DEVELOP ANY TREATMENTS, AND THERE WAS NO HARM TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRO TOPOLYZER VARIO CORNEAL TOPOGRAPHY SYSTEM MMQ WAVELIGHT GMBH 8065990710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1