BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1251951 · Received December 4, 2008

    Report

    Report Number
    1119421-2008-00982
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 4, 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
    IA, 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 11/05/2008, 11/06/2008 AND 11/20/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/21/2008. THIS REPORT WAS MAILED TO FDA ON: 12/04/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS WAS SLIGHTLY DECENTERED, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE LENS WAS EXCHANGED. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10738464

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PRESERVATIVE FREE EPINEPHRINE| BSS PRED FORTE| LIDOCAINE| DUOVISC