BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D

    MDR report key: 1924727 · Received December 9, 2010

    Report

    Report Number
    1119421-2010-01365
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ALL RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 12/01/2010 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 12/06/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE DELIVERY SYSTEM CARTRIDGE IS SPLITTING AND HAS STRIATIONS. IN A F/U, THE SURGEON EXPLAINED THAT DURING SURGERY, A CRACK IN THE CARTRIDGE CAUSED A SCRATCH ON THE IOL. THE IOL WAS REMOVED AND REPLACED WHICH REQUIRED A WIDENED WOUND AND A DIFFERENT CARTRIDGE WAS USED. AS A RESULT, THE PT EXPERIENCED WORSE CORNEAL EDEMA WHICH WAS TREATED WITH MEDICATION. THE EVENT RESOLVED AFTER SEVEN DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISCOELASTIC, IOL (INTRAOCULAR LENS)