BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1736207 · Received June 23, 2010

    Report

    Report Number
    1119421-2010-00731
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 05/26/2010, 05/28/2010, 06/02/2010, 06/08/2010 AND 06/11/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 06/17/2010. (B)(4). (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "WRONG POWER" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "NONE REPORTED" (NO KNOWN DEVICE PROBLEM [IOL (INTRAOCULAR LENS) IMPLANT]). A MATERIALS MANAGER REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO IOL BEING THE WRONG POWER. THE IOL WAS EXCHANGED FOR A SAME MODEL, DIFFERENT POWER LENS. IN A FOLLOW UP, IN THE OPINION OF THE SURGEON THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND THE EVENT HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10932597

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention VISCOELASTIC