BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 913331 · Received September 13, 2007

    Report

    Report Number
    1119421-2007-00377
    Event Type
    Other
    Date Received
    September 13, 2007
    Date of Event
    January 1, 2007
    Report Date
    August 14, 2007
    Manufacturer
    ALCON LABORATORIES, INC/HUNTINGTION
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 HAS BEEN ONE SIMILAR COMPLAINT REPORTED IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED 08/17/2007, 08/20/2007 AND 8/27/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 08/17/2007, 08/27/2007 AND 08/30/2007 BY PHONE AND MAIL.

    Description of Event or Problem · 1

    A CONSUMER REPORTS BLURRY VISION AT ALL DISTANCES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. LEFT EYE: MDR #1119421-2007-00376; RIGHT EYE: MDR #1119421-2007-00377.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTION SN60D3 957293

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other DUOVISC