BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2140023 · Received June 25, 2011

    Report

    Report Number
    2023826-2011-00563
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION:METHOD - LENS WORK ORDER SEARCH.RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC BROKEN. 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 INDICATED THE SURGEON INSERTED A 13.7MM VICM13.7 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) AND THE LENS TORE. THE LENS WAS REMOVED. AN ANTERIOR CHAMBER IRRIGATION/EVACUATION OF REMAINING VISCO/FLUIDS WAS PERFORMED. THE PATIENT HAD AN INTRAOCULAR INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY VICM 13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR INJECTOR MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK