BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1111527 · Received August 13, 2008

    Report

    Report Number
    1119421-2008-00589
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 14, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS BROKEN-GUSSET AREA (NOT RETURNED). THE OPTIC HAD SCRATCHES AND WAS SCRAPPED IN THE OPTIC CENTER. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OF ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THIS REPORT WAS MAILED TO FDA ON: 08/13/2008.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE HAPTIC WAS TORN OFF DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS REMOVED THE FOLLOWING DAY; THE INCISION WAS WIDENED AND SUTURES WERE USED TO CLOSE THE WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROVISC