BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 673606 · Received February 10, 2006

    Report

    Report Number
    1119421-2006-00033
    Event Type
    Other
    Date Received
    February 10, 2006
    Date of Event
    December 15, 2005
    Report Date
    January 11, 2006
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS A PATIENT IS SEEING A TEMPORAL SHADOW FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. NO INTERVENTION IS PLANNED AT THIS TIME. THE SURGEON HAS ADVISED THE PATIENT TO TAKE A WAIT AND SEE APPROACH TO SEE IF SYMPTOMS DIMINISH OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 922496

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other