BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMO INTRAOCULAR LENS

    MDR report key: 1050122 · Received May 20, 2008

    Report

    Report Number
    MW5007000
    Event Type
    Other
    Date Received
    May 20, 2008
    Date of Event
    March 19, 2007
    Report Date
    May 20, 2008
    Manufacturer
    AMO
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR IMPLANTED REZOOM LENS IN DIABETIC WITH PUPIL SIZE NOT SUITABLE FOR IOL. BEFORE SURGERY, PATIENT WAS NEAR SIGHTED IN LEFT EYE. AFTER SURGERY, PATIENT WAS FAR SIGHTED. PATIENT WAS NEVER INFORMED OF ANY SURGICAL ERRORS. LEFT EYE IOL WAS NOT CENTERED. DR WOULD NOT ADMIT ANY MISTAKES AND TRIED TO COVER IT UP WITH LASIK WHICH HAS CAUSED FURTHER SEVERE DRY EYE PROBLEMS. PATIENT HAS LOST NEAR VISION. CATARACT WAS NOT WASHED OUT OF RIGHT AND LEFT EYE CAUSING FURTHER SURGERIES. DR TOLD PATIENT THERE WAS NO REFRACTIVE ERROR. PATIENT HAD DOUBLE AND TRIPLE VISION AND THE DR REFUSED TO LISTEN. DR TOLD PATIENT, SHE WAS WASTING HIS TIME. I KNOW OF AT LEAST TWO OTHER PEOPLE THAT HE HAS DONE THIS TO. ONE OF THESE HAD THE SAME MISTAKES ON THE SAME DAY. HIS SURGERIES ARE LIKE A RUSHED ASSEMBLY LINE. I QUESTION THE ACCURACY OF HIS DIAGNOSIS WHICH HAS BEEN CONFIRMED BY A MEDICAL ADVISOR. THE SAME MEDICAL ADVISOR HAS CONFIRMED IOL LENSES WERE A BAD DECISION ON DRPART. DR MADE A SERIES OF BAD JUDGEMENTS. OFFICE RECORD KEEPING IS SLOPPY - WRONG PATIENT NAME ON REPORTS, RECORDS INDICATE OPERATING ON BOTH EYES WHEN IT WAS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO INTRAOCULAR LENS REZOOM LENS MFK AMO NXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other THERAPY DATES ARE| TO PRESENT