BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4962422 · Received August 3, 2015

    Report

    Report Number
    2023826-2015-01006
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 9, 2015
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4). METHOD: WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. (B)(4).

    Additional Manufacturer Narrative · 1

    WHILE THE LENS IS BEING EJECTED INTO THE ANTERIOR CHAMBER THE SURGEON MUST CHECK FOR LENS LANDMARKS TO ENSURE PROPER LENS ORIENTATION. IF THIS IS NOT DONE, THE LENS MAY END-UP BEING IMPLANTED UPSIDE-DOWN. ONCE THE SURGEON REALIZES OF THE IMPROPER ORIENTATION, THE LENS MUST BE REMOVED TO AVOID COMPLICATIONS AND A NEW LENS SHOULD BE IMPLANTED. THIS IS NORMALLY DONE USING THE SAME INCISION. THE MOST PROBABLE CAUSE OF THIS EVENT WAS USER'S ERROR WHILE LOADING/INJECTING THE LENS IN THE ANTERIOR CHAMBER. THE VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED THE 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT (OD) EYE UPSIDE DOWN. THE LENS WAS BROKEN WHILE REMOVING FROM THE EYE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505382 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR