BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3141010 · Received June 3, 2013

    Report

    Report Number
    2023826-2013-00358
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. UNINTENDED MOVEMENT. DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION:RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND 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 INSERTED A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS. UPON INSERTION, THE LENS FLIPPED AND WENT INTO THE PATIENT'S EYE UPSIDE DOWN. THE LENS WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE LENS TORE WHILE BEING REMOVED. THE BACKUP LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244242 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK