BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1905572 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01286
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 20, 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
    KS, 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 ALL RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 10/21/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 11/05/2010. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING AGENT REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS. IN THE OPINION OF THE SURGEON, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. IN A F/U, THE SURGEON REPORTED THE EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11039308

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DUOVISC