BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 707863 · Received April 18, 2006

    Report

    Report Number
    MW1038732
    Event Type
    Injury
    Date Received
    April 18, 2006
    Date of Event
    November 11, 2005
    Report Date
    April 18, 2006
    Manufacturer
    REFRACT
    Product Code
    HQR
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO THE OPHTHALMOLOGIST TO HAVE CK PROCEDURE DONE ON MY RIGHT EYE. I HAD 20/50 VISION PRIOR TO THE PROCEDURE. I WAS TOLD THAT I MIGHT HAVE SOME SLIGHT BLURRED VISION IMMEDIATELY POST PROCEDURE, BUT THAT THIS WOULD RESOLVE WITHIN 3 DAYS. IT HAS BEEN 5 MONTHS AND I REMAIN LEGALLY BLIND IN THE RIGHT EYE, BY DEFINITION. I HAVE GOTTEN A 2ND OPINION BY AN OPHTHALMOLOGIST AT ANOTHER HOSP, WHO STATES THAT HE FEELS THAT MY CURRENT VISUAL DEFICIT IS PERMANENT. THE SURGERY ITSELF APPEARS TO HAVE BEEN PERFORMED CORRECTLY, BUT THE DEGREE OF "CORRECTION" WAS WELL BEYOND ANTICIPATED OR DESIRED. THE PERFORMING SURGEON STATES THAT HE DOES NOT KNOW WHAT HAPPENED; HE HAS NEVER SEEN THIS BEFORE. I PUT IN AN INITAL REPORT, BUT DID NOT HAVE DEVICE INFO AT THE TIME. I AM NOW WONDERING IF THERE COULD BE A DEVICE PROBLEM WHICH RESULTED IN MIS-MEASUREMENT OR SOME OTHER PROBLEM WITH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VIEWPOINT CK SYSTEM HQR REFRACT RCS300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention