BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2901153 · Received January 4, 2013

    Report

    Report Number
    1119421-2013-00001
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    March 26, 2012
    Report Date
    December 7, 2012
    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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE VEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A CENTER DIRECTOR REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PATIENT BEING UNHAPPY WITH THE LENS. IN A FOLLOW UP, THE SURGEON REPORTED HE DOES NOT FEEL THE IOL CAUSED OR CONTRIBUTED TO THE EVENT. A LASIK PROCEDURE WAS PERFORMED PRIOR TO THE LENS EXCHANGE. THE SURGEON STATED THE PATIENT HAD VAGUE COMPLAINTS OF GLARE AND FELT HIS VISION WAS POOR QUALITY EVEN THOUGH HE MEASURED 20/20 UNCORRECTED BEFORE AND AFTER THE EXCHANGE PROCEDURE. THE SURGEON REPORTED THE PATIENT WAS LOST TO FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4704 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD./ HUNTINGTON SN6AD1 12063565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MONARCH III HANDPIECE| VIGAMOX| NEVANAC - DATES UNKNOWN| DUREZOL| PROVISC| MONARCH D CARTRIDGE