BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1870596 · Received October 12, 2010

    Report

    Report Number
    1119421-2010-01109
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    January 28, 2009
    Report Date
    September 12, 2010
    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 HAPTIC WAS RETURNED FOR ANALYSIS; THE REMAINDER OF THE DEVICE REMAINS IMPLANTED. THE HAPTIC WAS BENT AND BROKEN-GUSSET AREA. 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 INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DECENTRATION OF THE INTRAOCULAR LENS (IOL) WAS NOTED APPROXIMATELY TWO MONTHS FOLLOWING IMPLANT SURGERY. THEN APPROXIMATELY ONE YEAR LATER, A BROKEN HAPTIC WAS NOTED TO BE IN THE IRIS AND A SECONDARY SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE HAPTIC. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PATIENT HAS A HISTORY OF DOWN'S SYNDROME AND HAS A HABIT OF RUBBING HIS EYES OFTEN; THEREFORE, THE SURGEON CONSIDERED THIS TO BE THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON MA60BM 10822550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention