BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1970101 · Received January 14, 2011

    Report

    Report Number
    9612169-2011-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 13, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED DUE TO THE CONDITION OF THE RETURNED LENS. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING INSERTION OF AN INTRAOCULAR LENS (IOL), A JAGGED SPOT AND CIRCULAR CLOUDING AT THE PERIPHERY OF THE IOL WAS NOTED. THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS. THE SURGICAL PROCEDURE WAS DELAYED BY FIVE MINUTES. IN A F/U, THE SURGEON REPORTED THE EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 21008017

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC