BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1278077 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00934
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    January 1, 2005
    Report Date
    October 22, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS SEEING HALOS AROUND LIGHTS THAT HAS NOT IMPROVED IN THREE YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HER DOCTOR HAS PUT HER ON DROP THERAPY AND GIVEN HER SUNGLASSES WITH REFLECTIVE COATING; BUT NOTHING SEEMS TO HELP. SHE STATES THAT HER VISION IS GOOD. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. SA60D3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other