BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1063755 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00847
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 3, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (OTHER) - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS A PORTION OF THE PLATE HAPTIC TORN OFF AND IS MISSING. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR, FOAM TIP PLUNGER AND CARTRIDGE WERE NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 13.2MM AND A HAPTIC TORE. THE SURGEON REMOVED IT WITHOUT ANY PT INJURY. THE REPORTER STATED THAT THE LENS WAS DAMAGED DURING THE LOADING PROCESS.

    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 FOAM TIP PLUNGER: FTP| INJECTOR MODEL: MSI-TF| CARTRIDGE MODEL :SFC-45FP