BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 880297 · Received July 12, 2007

    Report

    Report Number
    1119421-2007-00291
    Event Type
    Other
    Date Received
    July 12, 2007
    Date of Event
    January 1, 2007
    Report Date
    June 12, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THAT THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THIS REPORT WAS MAILED TO THE FDA ON: 07/12/2007. ADDITIONAL INFORMATION WAS REQUESTED 06/13/2007, 06/15/2007, AND 06/25/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 06/13/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTS "SHUTTERS" OR DARK ARCS IN BOTH EYES. ADDITIONAL INFORMATION, INCLUDING PT STATUS, HAS BEEN REQUESTED. THIS REPORT IS FOR THE RIGHT EYE; LEFT EYE: MDR # 1119421-2007-00292.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC / HUNTINGTON SN60D3 125661

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other