BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2060892 · Received March 18, 2011

    Report

    Report Number
    1119421-2011-00303
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    November 10, 2010
    Report Date
    February 18, 2011
    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
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 02/18/2011, 02/21/2011 AND 03/10/2011 BY FAX, PHONE AND MAIL. THE SURGEON WAS NOT WILLING TO PROVIDE ANY ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING HALOS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON WAS NOT WILLING TO PROVIDE ANY ADDITIONAL INFORMATION. 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 SN6AD1 10870368

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other