BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1636668 · Received March 19, 2010

    Report

    Report Number
    1119421-2010-00330
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    November 18, 2009
    Report Date
    February 18, 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
    CO, 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 02/22/2010 AND 3/08/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/08/2010. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PATIENT EXPERIENCING POOR VISION AND DYSPHOTOPSIA. IN A FOLLOW-UP, THE NURSE REPORTED THE EVENT RESOLVED AFTER THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH. LTD. / HUNTINGTON SN6AD1 10948248

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention VISCOELASTIC