BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4201022 · Received October 27, 2014

    Report

    Report Number
    2023826-2014-00891
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS IMPLANTED. DEVICE MFG DATE: UNK. (B)(4). LENS IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REPORTEDLY, BY AN IMPLANTING SURGEON, THE PATIENT DID NOT ACHIEVE REFRACTIVE TARGET (PLANO) FOLLOWING ICL IMPLANTATION. THE SURGEON IS EXPLORING DIFFERENT OPTIONS FOR A CORRECTION OF A RESIDUAL REFRACTIVE ERROR. THE LENS IS STILL IMPLANTED. THERE WAS NO LOSS OF BCVA BEFORE AND AFTER SURGERY (20/25). IT SHOULD BE NOTED THAT PATIENT WAS (B)(6) AT THE TIME OF THE SURGERY AND PER DFU "INDICATIONS THE VISIAN ICL IS INDICATED FOR USE IN ADULTS 21-45 YEARS OF AGE". THEREFORE, THERE IS NO SUFFICIENT DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN MICL IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE. THE REPORTER INDICATED THERE WAS AN UNEXPECTED OUTCOME OF THE PATIENT'S VISUAL ACUITY DUE TO AN OVERCORRECTION/REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681741 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK