BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2803192 · Received October 24, 2012

    Report

    Report Number
    2023826-2012-00843
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    March 26, 2010
    Report Date
    September 24, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. IN THE US FDA CLINICAL TRIALS, APPROXIMATELY 6% TO 7% OF EYES DEVELOPED ANTERIOR SUBCAPSULAR OPACITIES AT 7 YEARS FOLLOWING ICL IMPLANTATION, BUT ONLY 1%-2% PROGRESSED TO CLINICALLY SIGNIFICANT CATARACT DURING THE SAME PERIOD. CATARACT EXTRACTION WAS PERFORMED IN THIS CASE WHICH RESOLVED THE PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - CATARACT, SURGICAL PROCEDURE, EXPLANTED. EVALUATION: METHOD - A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED THE MICL12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2009 AND A CATARACT WAS NOTED ON (B)(6) 2010. THE LENS WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH AN IOL. SEE MFR# 2023826-2012-00842 FOR THE REPORT ON THE RIGHT (OD) EYE.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention