BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1891613 · Received October 18, 2010

    Report

    Report Number
    1119421-2010-01142
    Event Type
    Other
    Date Received
    October 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    September 18, 2010
    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
    CA, 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. ADD'L INFO WAS REQUESTED ON 09/20/2010, 10/11/2010, AND 10/14/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES A CONSTANT BRIGHT LIGHT ENTERING HER EYE AT THE SURGICAL SITE. THE CONSUMER REPORTED THAT HER EYE IS NOW SMALLER, SET IN DEEPER ON HER FACE AND THE EYE DOES NOT OPEN AS WIDELY AS THE OTHER. THE CONSUMER REPORTED THAT THE PUFFY EYE BROW WHICH HAD NEARLY TOUCHED HER LASHES WAS ALSO GONE. SHE STATED THAT HER EYE BURNED AND SOMETIMES ACHED. IN A F/U CALL WITH THE CONSUMER, SHE REPORTED HAVING BEEN SEEN FOR A SECOND OPINION. THE CONSUMER STATED THE SURGEON TOLD HER THAT HER IRIS WAS THIN AT THE INCISION SITE AND THAT WAS WHAT WAS ALLOWING THE "GLARE-BEAM OF LIGHT" TO ENTER HER EYE. THE SURGEON TOLD HER THAT REPLACING THE LENS WOULD NOT CORRECT THE ISSUE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10981409

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other