BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1220383 · Received October 31, 2008

    Report

    Report Number
    1119421-2008-00861
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETUNED FOR ANALYSIS. THE PRODUCT DID NOT MEET RELEASE CRITERIA AND NO FURTHER INVESTIGATION WAS CONDUCTED. THE OPTIC WAS SCRATCHED NEAR THE TOPIC CENTER AND HAD LOOSE PARTICULATE. IN ADDITION, THE MICRO MARKS OBSERVED WHEN USING ALTERNATE MICROSCOPIC INSPECTION METHODS HAVE PREVIOUSLY BEEN INVESTIGATED AND DO NOT HAVE ANY NEGATIVE EFFECT ON VISUAL ACUITY. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER.

    Description of Event or Problem · 1

    A SURGEON REPORTED SEEING A SCRATCH ON AN INTRAOCULAR LENS (IOL) PRIOR TO IMPLANTATION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10751285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA