BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1185344 · Received October 2, 2008

    Report

    Report Number
    1119421-2008-00767
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 2, 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
    TX, 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 09/02/2008 AND 09/03/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 09/05/2008. THIS REPORT WAS MAILED TO FDA ON: 10/02/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED BECAUSE OF UNRESOLVED VISUAL DISTURBANCES. THE SURGEON FEELS THE PATIENT HAD HIGH ANGLE KAPPA AND COULD NOT TOLERATE A HIGH TECHNOLOGY OPTIC. IN A FOLLOW UP, THE SURGEON REPORTS THE PROGNOSIS FOR THE PATIENT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SA60D3 942265

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention VIGAMOX| OMNIPRED