BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL TIP CARTRIDGE

    MDR report key: 585693 · Received March 24, 2005

    Report

    Report Number
    2023826-2005-00306
    Event Type
    Malfunction
    Date Received
    March 24, 2005
    Date of Event
    February 22, 2005
    Report Date
    February 22, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO IMPLANT A LENS. THE LENS TORE AS IT WAS BEING ADVANCED IN THE CARTRIDGE. NO PT INJURY. THE FACILITY STATED THAT THE CAUSE OF THE LENS TEAR WAS DUE TO THE CARTRIDGE. THE INJECTOR MODEL MSI-PR, LOT NUMBER 1189285. THE FACILITY STATED THAT THERE WERE THREE ATTEMPTS FOR THE SAME PT PLEASE REFERENCE MFR REPORT # 2023826-2005-00305 & 2023826-2005-00307.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL TIP CARTRIDGE IOL INJECTION CARTRIDGE KYB STAAR SURGICAL CO. ST-45S 1170834

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR INJECTOR: MODEL MSI-PR, LOT: NUMBER 1189285,| LEN: MODEL AQ2003V, DIOPTER - 20.0.