BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1463617 · Received August 28, 2009

    Report

    Report Number
    1119421-2009-00822
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    May 20, 2009
    Report Date
    July 31, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 ON 08/03/2009, 08/04/2009, 08/18/2009, AND 08/19/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/18/2009. THIS REPORT WAS MAILED TO FDA ON: 08/28/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT SEEING A PERIPHERAL SHADOW FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON NOTED A SMALL AMOUNT OF CLOUDING OF THE IOL NASALLY. A YAG LASER TREATMENT WAS PERFORMED, BUT ENDED UP DAMAGING THE IOL. IN A FOLLOW UP, THE SURGEON NOTED THAT THE NEGATIVE DYSPHOTOPSIA CONTINUES, BUT IS NOT PRESENT WHEN THE PATIENT WEARS GLASSES. THE SURGEON NOTED THAT THE PATIENT DOES NOT WANT TO WEAR GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10862903

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VISCOELASTIC