BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1921969 · Received December 8, 2010

    Report

    Report Number
    1119421-2010-01350
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    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. ADD'L INFO WAS RECEIVED ON 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 LENS 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. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE LENS THAT WAS REMOVED DURING THE EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON MN60D3 964221

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR