BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1772297 · Received July 23, 2010

    Report

    Report Number
    1119421-2010-00853
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    May 21, 2010
    Report Date
    June 25, 2010
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 06/25/2010, 06/30/2010, 07/01/2010, AND WAS 07/06/2010 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS OBTAINED BY PHONE ON 07/01/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. NO FURTHER INFO IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "BLURRY VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "BROKEN HAPTIC" (BREAK [HAPTIC]). A PURCHASING AGENT REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED ONE WEEK FOLLOWING THE INITIAL SURGERY. IN A F/U, THE SURGEON FURTHER EXPLAINED THAT THE PT WAS EXPERIENCING BLURRY VISION DUE TO A BROKEN HAPTIC WHICH WAS A RESULT OF A LOADING ERROR. HE STATED THAT HE DOES NOT BLAME THE IOL FOR THE EVENT. THE LENS WAS EXCHANGED FOR THE SAME MODEL AND POWER IOL AND THE PT IS "DOING WELL WITH 20/20 VISION". NO FURTHER INFO IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 10912717

    Patients

    Seq Age Sex Outcome Treatment
    1