BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1083570 · Received July 24, 2008

    Report

    Report Number
    1119421-2008-00544
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 24, 2008
    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
    PA, US
    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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 06/24/2008, 06/26/2008, 07/01/200/, 07/07/2008, 07/08/2008 AND 07/17/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS DISSATISFACTION DUE TO FOGGY, BLURRED VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ALTHOUGH HER NEAR VISION IS 20/20 , SHE HAS DIFFICULTY ADJUSTING FROM DISTANCE TO NEAR QUICKLY AND NEEDS READING GLASSES TO MAKE THE ADJUSTMENT FASTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THE EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./ HUNTINGTON SN6AD3 10758704

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other