BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1221260 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00872
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AND RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED A POSTERIOR CAPSULAR BAG RUPTURE DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY DUE TO A FOLDING PROBLEM WITH THE LENS. THE OPTIC IS POSITIONED IN THE CENTER OF THE CAPSULAR BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WS 10754025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other