BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1616832 · Received February 10, 2010

    Report

    Report Number
    2023826-2010-00123
    Event Type
    Other
    Date Received
    February 10, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) -OTHER (NO DEVICE FAILURE): EVAL: METHOD (OTHER): LENS WORK ORDER SEARCH. RESULTS (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. (B) (4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PT'S EYE. THE PT MOVED WHEN THE LENS WAS BEING INSERTED AND CAUSED THE LENS TO POP OUT. THERE WAS NO PT INJURY. ADD'L INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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 39 YR CARTRIDGE: MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL MSI-PF - LOT NUMBER UNK