BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1128626 · Received August 20, 2008

    Report

    Report Number
    2023826-2008-01101
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 5, 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

    LENS WOULDN'T UNFOLD. EVAL RESULTS - A VISUAL INSPECTION OF THE RETURNED LENS SHOWS A SMALL PORTION OF A PLATE HAPTIC IS TORN OFF AND IS MISSING. THERE IS A CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR, FOAM TIP PLUNGER AND CARTRIDGE WERE NOT RETURNED FOR EVAL. A LENS SERIAL 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 INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 13.2MM IN THE PT'S EYE WITH NO PROBLEMS. HOWEVER, THE PT JERKED HER HEAD TO THE SIDE QUICKLY MAKING THE LENS COME OUT. THE SURGEON ATTEMPTED TO REINSERT THE LENS, AND IT WOULDN'T UNFOLD IN THE EYE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL MICL 13.2 NA

    Patients

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