BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1919358 · Received December 8, 2010

    Report

    Report Number
    1119421-2010-01349
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    December 10, 2009
    Report Date
    November 8, 2010
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFO WAS REQUESTED ON 11/08/2010, 11/19/2010, 11/10/2010, 11/15/2010 AND 11/22/2010 BY PHONE, MAIL AND FAX. ADDITIONAL INFO WAS RECEIVED 11/08/2010 AND 11/09/2010 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) DISLOCATED AND WAS EXCHANGED TWO DAYS FOLLOWING IMPLANT SURGERY. A VITRECTOMY WAS PERFORMED FOLLOWING THE REMOVAL OF THE INITIAL LENS AND A DIFFERENT MODEL WAS INSERTED INTO THE SULCUS; THE CAPSULE REMAINED INTACT. THIS LENS WAS NOT STABLE AND WAS REMOVED DURING THE SAME PROCEDURE. A SECOND LENS WAS SUCCESSFULLY IMPLANTED INTO THE SULCUS AND REMAINS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE FIRST, INITIALLY IMPLANTED, LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD / HUNTINGTON SN6AD1 10876116

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention