BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1013809 · Received March 14, 2008

    Report

    Report Number
    1119421-2008-00138
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 INFORMATION WAS REQUESTED 02/21/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 02/22/2008. THIS REPORT WAS MAILED TO FDA ON: 03/14/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PATIENT WITH GLISTENINGS IN BOTH EYES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. A DECREASE IN BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED. IN A FOLLOW-UP, THE SURGEON REPORTS THAT A LASER CAPSULOTOMY WAS PERFORMED. RESULTS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 934298

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention