BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3250882 · Received July 29, 2013

    Report

    Report Number
    2023826-2013-00608
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    May 20, 2013
    Report Date
    July 5, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW 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 A PIECE OF ONE HAPTIC BROKEN OFF AND MISSING. THE LENS WAS RETURNED DRY. MEDICAL REVIEW - A LENS TEAR MAY OCCUR DUE TO POOR LOADING TECHNIQUE INTO THE CARTRIDGE. IF THE SURGEON NOTICES THE TEAR ONLY AFTER DELIVERY INTO THE EYE, A REMOVAL CAN BE DONE USING THE SAME INCISION; IT IS NOT NECESSARY TO ENLARGE THE INCISION OR ADD ANY SUTURES THEREFORE THERE IS USUALLY NO IMPACT ON THE PATIENT'S VISION. A BROKEN ICL HAPTIC MAY LEAD TO ICL MALPOSITIONING, INSTABILITY, DECENTRATION, ETC. A NEW LENS WILL RESOLVE THE PROBLEM. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST PROBABLE CAUSE OF THIS EVENT IS A TEAR SECONDARY TO INAPPROPRIATE LOADING TECHNIQUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM 13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2013 DUE TO A REFRACTIVE SURPRISE OVERTIME. SUBSEQUENTLY, THE PATIENT EXPERIENCED ANGLE CLOSURE, WITH ELEVATED INTRAOCULAR PRESSURE (IOP). THE REPORTER INDICATED DURING LOADING OF THE LENS, ONE OF THE HAPTICS WAS BROKEN AND WHEN THE LENS WAS IMPLANTED, IT WOULD NOT POSITION WELL IN THE EYE. THE SURGEON ATTEMPTED TO RE-POSITION THE LENS. THE LENS WAS EXCHANGED FOR ANOTHER VICM 13.2, -11.00 DIOPTER AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353500 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK