BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1893232 · Received November 1, 2010

    Report

    Report Number
    1119421-2010-01195
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 2, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. 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 AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED SEVEN ADDITIONAL CASES OF INFLAMMATION AND CELLS IN THE ANTERIOR CHAMBER FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ALL OF THE SURGERIES INVOLVED UNCOMPLICATED CASES AND IOL IMPLANTATION. THE DURATION OF THE SURGERIES VARIED BETWEEN 17 AND 25 MINUTES. SOME PATIENTS (NOT SPECIFIED) WERE GIVEN PREOPERATIVE ARTIFICIAL TEARS OR GLAUCOMA MEDICATION. THE SURGEON STATED THAT MOST PATIENTS WILL BE FOLLOWED UP IN A COUPLE OF MONTHS. THIS PATIENT WAS TREATED WITH MEDICATIONS. IN A FOLLOW UP CONVERSATION WITH THE SURGEON, HE REPORTED HE IS NO LONGER ADDING LEVORENINE AND GEOMYCIN TO THE BSS AND THAT HE HAS IMPROVED HIS TECHNIQUE IN SURGERY. THE SURGEON REPORTED HE HAS NOT HAD ANY NEW CASES OF INFLAMMATION RECENTLY. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THE FIRST GROUP OF 21 PATIENTS HAS PREVIOUSLY BEEN REPORTED. THIS REPORT IS THE SECOND OF SEVEN. THIS IS A BILATERAL FILE, THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10807231

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention INDOCOLLYRE| BSS (WITH LEVORENINE AND GEOMYCIN)| LINISOL