BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMADEUS MONOBLOCK HANDPIECE

    MDR report key: 390341 · Received April 25, 2002

    Report

    Report Number
    2011068-2002-00003
    Event Type
    Other
    Date Received
    April 25, 2002
    Date of Event
    February 26, 2002
    Report Date
    April 24, 2002
    Manufacturer
    SURGICAL INSTRUMENT SYSTEMS, LTD (SIS)
    Product Code
    HMO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT REPORTEDLY EXPERIENCED A SEVERE IRREGULAR ASTIGMATISM FOLLOWING A MICROKERATOME PROCEDURE AND ABLATION. THE DOCTOR REPORTED THAT THE FLAP PRODUCED BY THE HANDPIECE APPEARED TO HAVE A THICK HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMADEUS MONOBLOCK HANDPIECE MICROKERATOME HMO SURGICAL INSTRUMENT SYSTEMS, LTD (SIS) 290719 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other AMADEUS MICROKERATOME SYSTEM