BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1172777 · Received September 19, 2008

    Report

    Report Number
    1119421-2008-00727
    Event Type
    Other
    Date Received
    September 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED INSIDE THE CARTON FOR EVALUATION. 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 08/21/2008, 08/28/2008, AND 09/03/2008 BY PHONE, FAX AND MAIL. THE SURGEON IS UNWILLING TO COMPLETE THE QUESTIONNAIRE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A VITREOUS LEAK OCCURRED UPON INSERTION OF THE IOL. IN A FOLLOW-UP THE SURGEON REPORTS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE VITREOUS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 10806951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other