BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3090831 · Received May 2, 2013

    Report

    Report Number
    2023826-2013-00334
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO - LENS NOT RETURNED. METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. THE LENS WAS RETURNED IN LIQUID. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS INSERTING A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS AND THE FRONT HAPTIC TORE. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. THE BACKUP LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191411 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

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