BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1221259 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00880
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 6, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED. BOTH HAPTICS WERE BROKEN (NOT RETURNED). THE OPTIC WAS CRACKED FROM ONE EDGE THROUGH THE CENTER. THE OPTICAL RESOLUTION IS ACCEPTABLE. THE FOCAL LENGTH READING IS 15.92 EQUALING A 23.5 DIOPTER. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. 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 ON 10/08/2008 AND 10/21/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 11/05/2008.

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTS A PATIENT EXPERIENCING DISTORTED AND DOUBLE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST WHO REPORTS RETINAL PIGMENT EPITHELIAL CHANGES THAT HE FELT WERE CONSISTENT WITH AGE RELATED MACULAR DEGENERATION. HE ALSO RECOMMENCED A LENS EXCHANGE. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 SN6AD3 10746045

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention