BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1062472 · Received June 18, 2008

    Report

    Report Number
    1119421-2008-00443
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 05/19/2008. ON 06/02/2008 AND 06/11/2008 BY PHONE AND MAIL. ADD'L INFO WAS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT DID NOT FEEL COMFORTABLE FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT STATED SHE FELT AS IF THERE WAS NOT ENOUGH LIGHT TO SEE CLEARLY. THE SURGEON STATED THERE WAS NO ERROR IN THE LENS CALCULATION. THE IOL IN THE RIGHT EYE (OD) WAS EXCHANGED WITH A DIFFERENT LENS MODEL. FOLLOWING THE IOL EXCHANGE OD, THE PT STATED SHE FELT VERY COMFORTABLE AND DID NOT WANT TO HAVE THE OTHER EYE (OS) EXCHANGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention