BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1153323 · Received September 5, 2008

    Report

    Report Number
    1119421-2008-00670
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 08/06/2008 AND 08/08/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/21/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH UNEXPECTED POSTOPERATIVE REFRACTIONS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. APPROX FOUR MONTHS LATER, A YAG WAS PERFORMED. IN FOLLOW UP, THE OUTCOME OF EVENT FOR THE PT IS "GOOD". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. SN6AD3 10738469

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention DUOVISC| UNPRESERVED LIDOCAINE