BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 947713 · Received November 8, 2007

    Report

    Report Number
    1119421-2007-00464
    Event Type
    Other
    Date Received
    November 8, 2007
    Date of Event
    January 1, 2007
    Report Date
    October 9, 2007
    Manufacturer
    ALCON MANUFACTURING, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. ADD'L INFO WAS REQUESTED 10/11/2007 BY FAX AND MAIL. PT RECORDS WERE RECEIVED 10/10/2007; ADDITIONAL INFO WAS RECEIVED BY PHONE ON 10/16/2007.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED BLURRY DISTANCE VISION. THE PT HAS EXCELLENT NEAR VISION. THERE ARE TWO MDRS ASSOCIATED WITH THIS EVENT: MDR # 1119421-2007-00465.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON MANUFACTURING, INC./HUNTINGTON SN60D3 133916

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ECONOPRED| NEVANAC| VIGAMOX