BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1991012 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00096
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 01/12/2011, 01/14/2011, 01/19/2011, 01/21/2011, AND 01/31/2011 BY PHONE, FAX, AND MAIL. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE HAPTIC BROKE ON THE IOL WHILE IT WAS BEING REMOVED. IN A FOLLOW-UP PHONE CALL WITH THE FACILITY, IT WAS REPORTED THAT THE PATIENT WAS MOVING DURING THE IOL IMPLANT PROCEDURE AND THE CAPSULE WAS UNSTABLE. THE POSTERIOR CAPSULE TORE AND WHILE THE SURGEON WAS REMOVING THE IOL, THE HAPTIC BROKE. A VITRECTOMY WAS PERFORMED. THE IOL WAS REPLACED WITH A DIFFERENT MODEL LENS. IN A FOLLOW UP WITH THE SURGEON, HE REPORTED THE EVENT RESOLVED. THE SURGEON DOES NOT FEEL THE LENS CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WS 11013461

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention DUOVISC| BSS