BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 734875 · Received July 14, 2006

    Report

    Report Number
    1119421-2006-00243
    Event Type
    Other
    Date Received
    July 14, 2006
    Report Date
    June 14, 2006
    Manufacturer
    ALCON LABS, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3., 6.: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A PT REPORTS SHE IS EXPERIENCING GLARE AND HAOLS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. BOTH EYES ARE AFFECTED. SHE WAS ADVISED TO DISCUSS HER CONCERNS WITH HER PHYSICIAN. IN RESPONSE, SHE STATED THAT SHE IS CURRENTLY SEEKING A SECOND OPINION REGARDING THE GLARE AND HALOS AND SHE DOES NOT WANT HER IMPLANTING SURGEON CONTACTED FOR ADDITIONAL INFO. DESPITE HER REPORTED CONCERNS, SHE FEELS THE IOLS ARE EXCELLENT ADDING THAT SHE DOES NOT NEED TO WEAR GLASSES. OS--MDR # 1119421-2006-00243, OD--MDR # 1119421-2006-00244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABS, INC./HUNTINGTON SA60D3 891298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other