BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH II IOL DELIVERY SYSTEM CARTRIDGE -UNKNOWN

    MDR report key: 1873021 · Received September 22, 2010

    Report

    Report Number
    1119421-2010-01055
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. NO CONTACT INFO WAS PROVIDED; THEREFORE, NO F/U COULD BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    THROUGH A MEDWATCH REPORT, A USER FACILITY REPORTED THAT THE DELIVERY SYSTEM CARTRIDGE WAS LOADED INCORRECTLY RESULTING IN THE INTRAOCULAR LENS BEING DELIVERED IN THE WRONG POSITION. THE SURGEON ROTATED THE LENS AND THE PT HAD A ZONULAR DEHISCENCE. ONE WEEK LATER, AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE IOL WAS EXCHANGED. THE REPORT ALSO INDICATED THAT A HOSPITAL INVESTIGATION WAS CONDUCTED AND IDENTIFIED ISSUES RELATED TO INCIDENT; THE SURGICAL TECH WHO LOADED THE IOL CARTRIDGE WAS RE-EDUCATED AND A REVIEW OF THE IOL DELIVERY SYSTEM WAS SCHEDULED FOR ALL DAY SURGERY STAFF. IT WAS REPORTED THAT THE PT IS "DOING WELL" AND HAS GOOD VISION. NO FURTHER INFO IS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRAOCULAR LENS (UNSPECIFIED)