BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2914539 · Received January 14, 2013

    Report

    Report Number
    2023826-2013-00036
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS AND THE LENS WAS NOTED TO BE TORN. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACK-UP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE LENS DAMAGE WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19979 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK