BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1211562 · Received October 3, 2008

    Report

    Report Number
    1119421-2008-00772
    Event Type
    Other
    Date Received
    October 3, 2008
    Date of Event
    July 11, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 WAS REQUESTED ON 09/09/2008 AND 09/11/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/17/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS DISCOMFORT, FOREIGN BODY SENSATION AND STATES SHE CAN SEE HER NOSE IN HER PERIPHERAL VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTS THAT THE PT MAY HAVE DRY EYE SYNDROME AND BELIEVES THIS MAY BE CONTRIBUTING TO HER FOREIGN BODY SENSATION. THE CONSUMER SOUGHT A SECOND OPINION AND WAS TOLD THAT SHE HAD A SUPERIOR LIMBIC KERATOCONJUNCTIVITIS (SLK). IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. FURTHERMORE, THE PT REPORTS HER VISION AS "EXCELLENT". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10820069

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other