BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1023862 · Received April 2, 2008

    Report

    Report Number
    2023826-2008-00457
    Event Type
    Other
    Date Received
    April 2, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 12, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS BOTH HAPTICS HAVE PIECES TORN OFF AND ARE MISSING. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR, CARTRIDGE AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON HAD INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 12.6MM AND THE LENS WAS TORN. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION AND REPLACED IT WITH ANOTHER SAME TYPE LENS. THE REPORTER STATED THAT THE LENS WAS LOADED IMPROPERLY.

    Devices

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

    Patients

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