BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER FUNNEL CARTRIDGE

    MDR report key: 624461 · Received July 20, 2005

    Report

    Report Number
    2023826-2005-00965
    Event Type
    Malfunction
    Date Received
    July 20, 2005
    Date of Event
    June 20, 2005
    Report Date
    June 20, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT AN +18.0 DIOPTER CC4204BF COLLAMER PLATE LENS BUT IT TORE WHILE ADVANCING THROUGH THE CARTRIDGE. THE REPORTER STATED THE CARTRIDGE SPLIT AND THIS MAY HAVE BEEN THE CAUSE OF THE LENS TEAR. THERE WAS NO PATIENT CONTACT OR INJURY. THIS IS ONE OF THREE LENSES FOR THE SAME PATIENT. PLEASE REFERENCE 2023826-2005-00964 AND 2023826-2005-00966.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER FUNNEL CARTRIDGE IOL INJECTION CARTRIDGE KYB STAAR SURGICAL CO. SFC-25 FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR