BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFRACTEC

    MDR report key: 564382 · Received November 30, 2004

    Report

    Report Number
    MW1034206
    Event Type
    Injury
    Date Received
    November 30, 2004
    Date of Event
    January 29, 2004
    Report Date
    November 30, 2004
    Manufacturer
    UNK
    Product Code
    HQR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT AHD CONDUCTIVE KERATOPLASTY DONE AT THE EYE CARE CENTER. IT CREATED AN ASTIGMATISM IN LEFT EYE THAT WAS LATER TREATED BY LASEK. BEFORE PT HAD20/20 VISION IN THAT EYE. NOW PT CANNOT SEE WITHOUT A SOFT CONTACT LENS AND GLASSES BOTH AT TIMES. WITHOUT CORRECTION PT CAN'T DRIVE AT NIGHT AND HAS SEVERE HEADACHES. DR TELLS PT THAT THEIR EYE ARE FINE AND THAT PT JUST NEEDS TO ADJUST TO THE BLENDED MONOVISION. PT FINDS IT STRANGE THEY DIDN'T TELL THEM ABOUT THE PROBLEM THAT THEY AND THE REFRACTEC MACHINE CAUSED FOR OVER SEVEN WEEKS. PT IS RETIRING FROM THEIR POSITION BECAUSE I NO LONGER FEEL SAFE WITH BLURRED VISION AND HALOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFRACTEC CK PROCEDURE DEVICE HQR UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention| S