BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1991010 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00101
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    October 13, 2010
    Report Date
    January 7, 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
    FL, US
    Reporter Occupation
    NURSE

    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 01/14/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/03/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS STARTED SINKING IN THE EYE. THE SURGEON IMMEDIATELY REMOVED AND REPLACED THE IOL. IN A FOLLOW-UP, THE SURGEON EXPLAINED THAT THERE WAS A CAPSULE RUPTURE AND A VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11071389

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VISCOAT/PROVISC| MONARCH DELIVERY SYSTEM