BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1587840 · Received January 15, 2010

    Report

    Report Number
    9612169-2010-00001
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    October 20, 2009
    Report Date
    December 16, 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
    CA
    Reporter Occupation
    OTHER

    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 WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WITH NEGATIVE DYSPHOTOPSIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT NOTED A DARK LATERAL ARC IN THE VISUAL FIELD. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 10915135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other DISCOVISC| MIOCHOL| TOBRADEX| BSS| OCCUCOAT