BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1082568 · Received July 25, 2008

    Report

    Report Number
    1119421-2008-00563
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 26, 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 REPORTER STATED THE DEVICE SAMPLE WILL BE SENT FOR EVAL. THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADDITIONAL INFO WAS REQUESTED. A COMPLETED QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE INTRAOCULAR LENS (IOL) HAD DIFFICULTY ADVANCING THROUGH THE DELIVERY SYSTEM DURING IMPLANT SURGERY. THE IOL WAS NOTED TO HAVE A BROKEN HAPTIC WHEN IT WAS INSERTED INTO THE EYE. DURING THE PROCEDURE THE PLUNGER TOUCHED THE IRIS AND BLEEDING OCCURED. THE DAMAGED IOL WAS LEFT IN THE EYE AT THAT TIME, DUE TO THE BLEEDING IRIS. THE PATIENT'S EYE WAS FINE DURING THE FOLLOW-UP VISIT, HOWEVER, THE IOL WAS NOTED TO BE DECENTERED. THE IOL WAS EXCHANGED FOR A DIFFERENT IOL FOR THE SAME MODEL APPROXIMATELY ONE WEEK FOLLOWING THE INITIAL IMPLANT SURGERY. ONE DAY FOLLOWING IOL EXCHANGE, THE PT WAS REPORTED TO BE FINE, BUT HER VISION STILL NEEDS TO IMPROVE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN60D3 10756057

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention