BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1153326 · Received September 5, 2008

    Report

    Report Number
    1119421-2008-00660
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 6, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LENS WAS RETURNED FOR EVALUATION AND THE LENS RESOLUTION AND DIOPTER WERE ACCEPTABLE. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MFG 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 INFO WAS REQUESTED ON 08/06/2008 AND 08/13/2008 BY PHONE, FAX AND MAIL; AND RECEIVED ON 08/14/2008. THIS REPORT WAS MAILED TO FDA ON: 09/05/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT EXPERIENCING BLURRING OF VISION AND DIPLOPIA FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. APPROX FIVE MONTHS LATER, THE LENS WAS EXCHANGED. 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. SN6AD3 10744148

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention