BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 851294 · Received May 4, 2007

    Report

    Report Number
    1119421-2007-00171
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 6, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ARE NO OTHER COMPLAINTS FOR THIS LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 04/17/2007, 04/18/2007, AND 04/19/2007 BY PHONE, MAIL AND FAX. NO ADD'L INFO HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CONSUMER REPORTS THAT SHE CANNOT SEE AT NIGHT, CANNOT SEE IN THE GROCERY STORE, AND CANNOT SEE HER COMPUTER. TWO REPORTS FILED FOR THIS EVENT. FIRST EYE: MDR 1119421-2007-00170. SECOND EYE: MDR 1119421-2007-00171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 958879

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other