BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1251950 · Received December 4, 2008

    Report

    Report Number
    1119421-2008-00981
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 30, 2008
    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
    VA, 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 10/31/2008, 11/03/2008, 11/04/2008 AND 11/14/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE SURGEON.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED 17 MONTHS FOLLOWING IMPLANT SURGERY DUE TO THE PATIENT REPORTING GLARE AND DECREASED VISUAL ACUITY. THE SURGEON REPORTED THE PATIENT WAS ALSO EXPERIENCING DYSPHOTOPSIA AND WAXY VISION. TWO MONTHS FOLLOWING THE INITIAL IMPLANT, PCO WAS NOTED. A YAG LASER PROCEDURE WAS PERFORMED ONE MONTH LATER. FOLLOWING THE EXCHANGE, THE SURGEON REPORTED THAT THE PATIENT WAS DOING WELL. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "POOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 10604559

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention