BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D

    MDR report key: 1210005 · Received October 22, 2008

    Report

    Report Number
    1119421-2008-00825
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 22, 2008
    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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE REPORTING FACILITY. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE FACILITY DID NOT PROVIDE A PRODUCT LOT NUMBER FOR THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED ON 09/23/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/06/2008. THIS REPORT WAS MAILED TO FDA ON: 10/22/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A PATIENT WITH A CAPSULAR BAG TEAR AFTER A LENS POPPED OUT OF A CARTRIDGE DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. A SURGEON REPORTED THAT AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. IN A FOLLOW-UP, THE SURGEON REPORTED THE OUTCOME OF THE EVENT AS "EXCELLENT".

    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 77 YR Required Intervention