BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943728 · Received December 16, 2010

    Report

    Report Number
    1119421-2010-01427
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 29, 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
    CA
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT LESS THAN A WEEK FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE BEGAN EXPERIENCING VISUAL DISTURBANCES. THE CONSUMER REPORTED THAT WHILE HER VISION IS NEAR PERFECT, IT IS IMPAIRED BY A SECOND IMAGE THAT SHE SEES. SHE REPORTED BLURRED NEAR VISION, PROBLEMS WITH NIGHT AND LOW LIGHT CONDITIONS, TROUBLE SEEING STREET SIGNS AND PEOPLE DUE TO ONCOMING HEADLIGHTS AND HALOS. SHE REPORTED SHE IS AN (B)(6) AND WAS HAVING DIFFICULTY PERFORMING BASIC RESPONSIBILITIES WHICH WERE COMPOUNDED BY THE FACT THAT SHE HAS WORK SHORTENED HOURS BECAUSE SHE CANNOT DRIVE IN LOW LIGHT OR NIGHT CONDITIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10902169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other