BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVESCAN WAVEFRONT SYSTEM

    MDR report key: 1884179 · Received October 7, 2010

    Report

    Report Number
    3006695864-2010-00116
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 17, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HKO
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DETERMINED THAT THE EVENT WAS CAUSED BY THE USER AND DECLINED CLINICAL OR SERVICE SUPPORT. THE CUSTOMER DECIDED TO HANDLE THIS ISSUE INTERNALLY AND WOULD NOT PROVIDE ANY FURTHER INFO.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM A REFRACTIVE SPECIALIST REPORTING THAT A CUSTOMER EXPERIENCED WHAT THEY INITIALLY BELIEVED BE AN ERRANT CUSTOM VUE TREATMENT. ACCORDING TO THE REPORT, THE CYLINDAR AXIS ON THE WAVESCAN WAS ALMOST 90 DEGREES OFF OF THE MANIFEST AND KERATOMETRY. THE PT WAS TREATED WITH THE WAVESCAN TREATMENT PLANS FOR A LASIK VISION CORRECTION AND REC'D A SIGNIFICANT INDUCED CYLINDAR IN BOTH EYES. UPON FURTHER INVESTIGATION, THE CLINIC DISCOVERED THAT THE TECHNICIAN OPERATING THE WAVESCAN REVERSED THE EYES BEING SCANNED AND IGNORED THE WAVESCAN WARNINGS. THE TREATMENT PLANS WERE CREATED FOR THE RIGHT EYE USING THE PT'S LEFT EYE AND VICE VERSUS. THE CUSTOMER REPORTED THAT THIS WAS A USER ERROR AND DECLINED TO PROVIDE ANY ADD'L INFO ON THIS EVENT INCLUDING THE NAME OF THE CLINIC WHERE THE EVENT OCCURRED AND THE SERIAL NUMBER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESCAN WAVEFRONT SYSTEM HKO AMO MANUFACTURING USA, LLC UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other