BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943516 · Received December 2, 2010

    Report

    Report Number
    1119421-2010-01329
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTICED THAT OBJECTS ARE DISTINCT, BUT DOUBLED AND EVENT TRIPLED (LIKE SHADOWS NEAR OBJECTS), THOUGH THE COLORS ARE BRIGHT. THE CONSUMER REPORTED THAT BEFORE IMPLANTATION, HE COULD SEE TWO LINES OF THE SNELLEN CHART; AND AFTER IMPLANTATION, HE COULD SEE SEVEN LINES OF THE SNELLEN CHART. HE REPORTED THAT HE WAS GIVEN A PRESCRIPTION FOR READING GLASSES. IN A F/U, THE SURGEON REPORTED THERE WERE NO MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10942957

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other VISCOAT| PROVISC| CELOFTAL