BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1023606 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00199
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 27, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER REPORTS IN THE LOT. ADDITIONAL INFO WAS REQUESTED BY PHONE ON 02/28/2008. PATIENT RECORDS WERE RECEIVED VIA FAX FROM THE SURGEON. THIS REPORT WAS MAILED TO FDA ON: 03/28/2008.

    Description of Event or Problem · 1

    A SURGEON STATED A PT REPORTED SEEING GHOSTING FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE IOL DECENTERED. AN ADDITIONAL SURGICAL PROCEDURE IS PLANNED IN ORDER TO RECENTER THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10732378

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention