BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2884695 · Received December 24, 2012

    Report

    Report Number
    2023826-2012-01003
    Event Type
    Injury
    Date Received
    December 24, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT - UNK DATE OF EVENT - UNK (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. METHOD: WORK ORDER SEARCH RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: 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

    METHOD - MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS HAD A DRIED SURGICAL RESIDUE ON IT, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT HAD BLURRY VISION AFTER ICL IMPLANTATION. THE ICL WAS EXCHANGED FROM A 4.5D TO A 6.0D WHICH RESOLVED THE PROBLEM. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS IMPLANTATION OF AN UNDER POWERED ICL WHICH RESULTED IN A REFRACTIVE SURPRISE. REFRACTIVE SURPRISE IS USUALLY DUE TO INACCURATE REFRACTIONS. THESE MYOPES COMMONLY WEAR CONTACT LENSES PRIOR TO THIS CONTEMPLATED PROCEDURE. CONTACT LENSES CHANGE THE SHAPE OF YOUR CORNEA FOR UP TO SEVERAL WEEKS AFTER YOU HAVE STOPPED USING THEM DEPENDING ON THE TYPE OF CONTACT LENSES YOU WEAR. NOT LEAVING YOUR CONTACT LENSES OUT LONG ENOUGH FOR YOUR CORNEA TO ASSUME ITS NATURAL SHAPE BEFORE SURGERY CAN HAVE NEGATIVE CONSEQUENCES. THESE CONSEQUENCES INCLUDE INACCURATE MEASUREMENTS AND A POOR SURGICAL PLAN, RESULTING IN POOR VISION AFTER SURGERY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO A LARGER DIOPTER LENS WAS REQUIRED FOR THE PATIENT (A -6.00 DIOPTER MICL12.6 MODEL LENS WAS IMPLANTED.). THE PATIENT EXPERIENCED BLURRY VISION. THE PATIENT'S BCVA WAS 20/20 AND THE PATIENT IS HAPPY WITH HER VA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK