BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1474605 · Received September 9, 2009

    Report

    Report Number
    1119421-2009-00846
    Event Type
    Other
    Date Received
    September 9, 2009
    Date of Event
    January 1, 2009
    Report Date
    May 14, 2009
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. THE REPORTER SENT DVDS INSTEAD WHICH SHOWED A SERIES OF SLIT LAMP EXAMS. UPON REVIEW OF THE DVDS, GLISTENINGS WERE OBSERVED ALONG WITH PCO, THERE WAS PHIMOSIS AND DISLOCATION. 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. THIS REPORT WAS MAILED TO FDA ON: 09/09/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED NOTING OPACIFICATION ON AN INTRAOCULAR LENS (IOL) FOUR YEARS FOLLOWING IMPLANT SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60AT 849014

    Patients

    Seq Age Sex Outcome Treatment
    1