BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1023856 · Received April 1, 2008

    Report

    Report Number
    1119421-2008-00203
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 2, 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
    TX, 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 INFO WAS REQUESTED 03/10/2008 BY FAX AND MAIL. A FOLLOW-UP QUESTIONNAIRE WAS RECEIVED FROM THE SURGEON. THIS REPORT WAS MAILED TO FDA ON: 04/01/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS DISTORTED VISION AND DECREASED NEAR AND FAR VISION FOLLOWING INTRAOCULAR LENS ( IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTS PROGNOSIS AS " EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10727326

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other