BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1051639 · Received May 21, 2008

    Report

    Report Number
    1119421-2008-00365
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    February 2, 2004
    Report Date
    April 21, 2008
    Manufacturer
    ALCON RESEARCH LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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.

    Description of Event or Problem · 1

    AN ATTORNEY'S OFFICE PROVIDED MEDICAL RECORDS REGARDING A CONSUMER'S INTRAOCULAR LENS (IOL) REMOVAL. THE REMOVAL WAS DUE TO THE IOL BEING SCARRED TO THE OLD DONOR CORNEA DURING A NEW CORNEAL GRAFT TRANSPLANT SURGERY. THIS WAS THE PATIENT'S SECOND CORNEAL TRANSPLANT ON THE SAME EYE (OS). THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ATTORNEY'S REPORT FOR THE DIFFERENT IOL'S USED IN THIS CONSUMER'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD. / HUNTINGTON MA60AC 716366

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention