BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1369394 · Received April 24, 2009

    Report

    Report Number
    9612169-2009-00010
    Event Type
    Other
    Date Received
    April 24, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 26, 2009
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. THIS REPORT WAS MAILED TO FDA ON: 04/24/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING GLARE AND HAZY VISION FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON ALSO REPORTS THAT ON EXAMINATION, THE IOL HAS THOUSANDS OF LITTLE DOTS THROUGH THE WHOLE MATERIAL. IN A FOLLOW UP, THE SURGEON REPORTED THAT THE PATIENT'S SYMPTOMS CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 988767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VISCOELASTIC