BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1365011 · Received April 17, 2009

    Report

    Report Number
    9612169-2009-00008
    Event Type
    Other
    Date Received
    April 17, 2009
    Date of Event
    November 1, 2008
    Report Date
    March 18, 2009
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    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 NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B) (4). EYE PAIN. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING PAIN, DECREASED VISION, AND SEEING A "DIAGONAL REFLECTION" FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE ALSO REPORTED THAT SHE WAS GIVEN MEDICATION FOR HER SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 20800690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other