BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1210116 · Received October 22, 2008

    Report

    Report Number
    1119421-2008-00823
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 22, 2008
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND ONE HAPTIC WAS OBSERVED PULLED OUT OF THE OPTIC. THIS HAPTIC WAS BENT IN THE GUSSET AREA. THE OTHER HAPTIC WAS BENT IN THE DISTAL AREA WITH SUTURE MATERIAL STILL TIED ON THE HAPTIC. THE OPTIC HAD SCRATCHES AND THE OPTIC WAS TORN/SPLIT/CRACKED IN THE HAPTIC INSERTION AREA OF THE REMOVED HAPTIC. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/22/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT EXPERIENCING VISUAL IMPAIRMENT TWO MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY FOR THE RIGHT EYE. THE LENS WAS IMPLANTED IN THE "OUT OF THE BAG" MANNER AND FIXED BY SUTURE. DURING A POSTOPERATIVE VISIT, THE LENS WAS NOTED TO BE DECENTERED AND THAT ONE OF THE HAPTICS DROPPED FROM THE OPTIC. APPROXIMATELY, TWO WEEKS LATER, THE LENS WAS EXCHANGED. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PATIENT'S VISION IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA50BM 10807861

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention