BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1063489 · Received June 20, 2008

    Report

    Report Number
    1119421-2008-00468
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 23, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT WAS NOT OBSERVED. THE RETURNED LENS WAS IN A CONTAINER FLOATING IN A CLEAR WATERY SUBSTANCE (SOLUTION). THE OPTIC HAD SCRATCHES AND THE OPTIC WAS TORN/SPLIT/CRACKED INTO TWO PIECES )POSSIBLY CUT); HOWEVER,THE OPTIC DID NOT APPEAR TO BE WARPED (DEFORMED) AS DESCRIBED BY THE USER FACILITY. DIMENSIONS COULD NOT BE MEASURED DUE TO THE CONDITION OF THE RETURNED PRODUCT. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 05/27/2008 BY FAX AND BY MAIL AND ON 06/10/2008 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/20/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HE THOUGHT THE INTRAOCULAR LENS (IOL) WAS WARPED AND WAS INDUCING ABERRATIONS IN THE PATIENT'S VISION. THE IOL WAS EXPLANTED. THE PATIENT'S SYMPTOMS RESOLVED FOLLOWING THE IOL EXCHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention