BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2003717 · Received February 23, 2011

    Report

    Report Number
    1119421-2011-00183
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 24, 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
    CA, 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 NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 01/28/2011, 01/31/2011, AND 02/08/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/10/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS. THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE EXCHANGE PROCEDURE. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11075463

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention MONARCH DELIVERY SYSTEM| VISCOAT| OCCUCOAT