BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVESCAN WAVEFRONT SYSTEM

    MDR report key: 2072656 · Received April 22, 2011

    Report

    Report Number
    3006695864-2011-00028
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HKO
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SVC ENGINEER TESTED AND INSPECTED THE WAVESCAN WAVEFRONT DEVICE AT THE CUSTOMER LOCATION AND MADE ADJUSTMENTS TO THE CAMERA GAIN. ALL CALIBRATIONS WERE FOUND TO BE WITHIN THE SPECIFICATION. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED EXPERIENCING A LOT OF PTS WITH A VISUAL ACUITY OF 20/30 FOLLOWING LASER VISION CORRECTION AND REQUESTED INSPECTION OF THE EQUIPMENT. THE CUSTOMER HAS DECLINED TO PROVIDE ANY FURTHER CLINICAL INFO. IT IS NOT KNOWN HOW MANY PTS ARE INVOLVED AND WHETHER THE RESULTS REPORTED ARE FOR BEST CORRECTED VISUAL ACUITY OR UNCORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESCAN WAVEFRONT SYSTEM HKO AMO MANUFACTURING USA, LLC WS1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other