BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3911189 · Received July 2, 2014

    Report

    Report Number
    2023826-2014-00496
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 31, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 ONE HAPTIC TORN. 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. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST PROBABLE CAUSE OF THE EVENT IS LENS TEAR SECONDARY TO INAPPROPRIATE LOADING OF THE ICL INTO THE CARTRIDGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT; TORN MATERIAL; BREAK. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) BUT THE LENS TORE/BROKE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL/DIOPTER LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385997 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK