BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1278078 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00940
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    November 1, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS 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 10/24/2008 AND 11/03/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS TWO PATIENTS WITH UNEXPECTED POSTOPERATIVE REFRACTIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTS THAT THIS EVENT IS NOT LENS-RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE FIRST OF TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN60WF 10822253

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other