BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1913357 · Received November 11, 2010

    Report

    Report Number
    1119421-2010-01233
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 12, 2010
    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
    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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, A PT WHOSE INTRAOCULAR LENS (IOL) APPEARS OPACIFIED IN THE POSTERIOR PART AND CLEAR IN THE ANTERIOR PART. THE IOL WAS IMPLANTED IN 2003. A VITRECTOMY WAS ALSO PERFORMED AT THE TIME OF THE IOL IMPLANT SURGERY FOR A VITREAL HEMORRHAGE. THE PT HAS A HISTORY OF DIABETES AND HAS RETINAL PATHOLOGY. 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 SN60AT 764002

    Patients

    Seq Age Sex Outcome Treatment
    1