BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1061031 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00829
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 30, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - A LENS SERIAL WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WHICH SHOWS NO SIMILAR COMPLAINTS. A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS STUCK IN THE CARTRIDGE. THERE IS CLEAR SURGICAL RESIDUE ON THE CARTRIDGE. IT SHOULD BE NOTED THAT THE INJECTOR AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS ADVANCING A IMPLANTABLE COLLAMER LENS MODEL MICL 12.6 IN THE CARTRIDGE AND NOTICED A HAPTIC WAS DAMAGED SO, HE QUIT USING THE LENS. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL MSI-PF LOT#UNK| FOAM TIP PLUNGER: FTP LOT#UNK| CARTRIDGE: MODEL SFC-45FP LOT#UNK