BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2000353 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00172
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 20, 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
    MI, US
    Reporter Occupation
    OTHER

    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 LUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 01/24/2011, 01/25/2011, AND 01/26/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/25/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP PHONE CALL WITH THE SURGEON'S OFFICE A TECHNICIAN REPORTED THERE WAS NO UNEXPECTED POSTOPERATIVE REFRACTION. THE PATIENT WAS UNHAPPY WITH HER VISION WHICH WAS CAUSED BY CYSTOID MACULAR EDEMA (CME). THE PATIENT WAS BEING FOLLOWED BY A RETINA SPECIALIST WHO WAS TREATING THE PATIENT WITH MEDICATIONS. IN A FOLLOW UP, THE SURGEON REPORTED THE CME IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10938137

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention