BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3830091 · Received May 1, 2014

    Report

    Report Number
    9612169-2014-00051
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A LENS AND A HANDPIECE WERE RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THE LENS LOT NUMBER. A COMPLAINT HISTORY REVIEW FOR THE HANDPIECE INDICATES FOUR ADDITIONAL COMPLAINTS WERE ASSOCIATED WITH THIS LOT NUMBER. TWO OF THE HANDPIECES FORM THE SAME LOT NUMBER HAVE FOUR OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC BROKE. DURING THE LENS EXCHANGE THE CAPSULAR BAG TORE AND A LENS WAS PLACED IN THE SULCUS. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261835 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21098054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MONARCH III HANDPIECE| MONARCH D CARTRIDGE| DUOVISC