BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1992854 · Received February 4, 2011

    Report

    Report Number
    1119421-2011-00066
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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 INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AT A ONE YEAR ROUTINE EXAMINATION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SAW THAT THE PT'S LENS WAS FULL OF SOMETHING THAT APPEARED TO BE VACUOLES INSIDE THE LENS MATERIAL. AT THE TIME OF HER EXAMINATION, THE SURGEON NOTED THE PT HAD A RETINAL DETACHMENT, SO THE SURGEON COULD NOT TELL IF THE VACUOLES WERE AFFECTING THE PT'S VISION. THE SURGEON REPORTED SHE WAS NOT THE OPERATING SURGEON AND WAS NOT SURE IF THE RETINAL DETACHMENT OCCURRED BEFORE OR AFTER THE IMPLANT PROCEDURE. IN A FOLLOW UP WITH THE SURGEON, SHE REPORTED THAT SHE NOTICED PARTICLES OF DUST INCORPORATED IN THE IOL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1