BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1031590 · Received March 19, 2008

    Report

    Report Number
    2023826-2008-00411
    Event Type
    Injury
    Date Received
    March 19, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND NO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED, THAT THE SURGEON ATTEMPTED TO INSERT A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 12.6MM AND THE LENS WOULDN'T MOVE PROPERLY IN THE INJECTOR AND THE SURGEON REMOVED THE INJECTOR FROM THE EYE AND EJECTED THE LENS ONTO THE STERILE FIELD AND A PIECE OF A HAPTIC WAS TORN OFF AND MISSING. THERE WAS PATIENT CONTACT WITH THE INJECTOR BUT NOT THE LENS. A SUTURE WAS USED IN THE SELERAL TUNNEL TO CLOSE THE INCISION. THE LENS WAS THE REPLACEMENT LENS FOR ANOTHER MICL LENS. SEE MANUFACTURER REPORT NUMBER 2023826-2008-00410 FOR THE OTHER INCIDENT.

    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 Required Intervention CARTRIDGE MODEL: SFC-45FP| INJECTOR MODEL: MSI-PF| FOAM TIP PLUNGER: FTP LOT