BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - C

    MDR report key: 1013807 · Received March 14, 2008

    Report

    Report Number
    1119421-2008-00144
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    K063768
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 03/05/2008 BY MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTICED WHITE DEPOSITS ON THE POSTERIOR SIDE OF THE LENS. THE LENS WAS REMOVED THROUGH AN ENLARGED INCISION. THE PATIENT DEVELOPED MILD CORNEAL EDEMA FOLLOWING THE PROCEDURE. IN A FOLLOW-UP, THE SURGEON REPORTS OUTCOME OF EVENT AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - C LENS GUIDE KYB ALCON RESEARCH, LTD. / HUNTINGTON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention