BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4111779 · Received September 23, 2014

    Report

    Report Number
    2023526-2014-00691
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    April 5, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S BUT NOT MARKETED IN THE U.S. (B)(4). 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

    (B)(4) SUBMISSION NAME FOR MFR REPORT # 2023526-2014-00691 IS INCORRECT. SUBMITTED 09/23/2014. CORRECT SUBMISSION NAME: MFR REPORT # 2023826-2014-00691.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN 12.6 VICMO12.6 IMPLANTABLE COLLAMER LENS IN PATIENT'S LEFT EYE ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. ON (B)(6) 2014, PATIENT'S LAST VISIT; UCVA WAS 20/13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590530 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| FORM TIP PLUNGER AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK