BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1993405 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00098
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 11, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 INFO WAS REQUESTED ON 01/13/2011, 01/17/2011, AND 01/25/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/02/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTED SURGERY. THE SURGEON REPORTED THE PT IS NOT SATISFIED WITH HER VISION, SHE IS A BLURRED 20/30. THE PT HAD A HISTORY OF DRY EYES (PRE-EXISTING). IN A FOLLOW UP, THE SURGEON DOES NOT FEEL THE IOL CAUSED OR CONTRIBUTED TO THE EVENT. HE IS NOT SURE IF IT WAS THE INITIAL CALCULATIONS OR WHAT CONTRIBUTED TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10938154

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other PROVISC| MONARCH DELIVERY SYSTEM