BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2833998 · Received November 15, 2012

    Report

    Report Number
    2023826-2012-00910
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 23, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD - LENS WORK ORDER SEARCH & MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED DRY, A HAPTIC WAS TORN AND THERE WAS A FOREIGN MATERIAL ON THE SURFACE OF THE LENS. THE LENS WAS RE-MEASURED AND FOUND TO BE WITHIN THE ORIGINAL DESIGN SPECIFICATIONS. THEREFORE, IT CAN BE JUSTIFIED THAT THE COMPLAINT IS NOT PRODUCT RELATED. A LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. SEVERAL FACTORS MAY PLAY A ROLE IN CATARACT DEVELOPMENT (AGE, DEGREE OF MYOPIA, SYSTEMIC DISEASES, MEDICATIONS, SURGICAL MANIPULATIONS) ALTERED AQUEOUS FLOW IN THE PRESENCE OF AN ICL, ECT. CLINICAL STUDIES HAVE SHOWN THAT ANTERIOR SUB-CAPSULAR CATARACT OCCURS IN 1.3% OF PATIENTS WHERE AN ICL HAS BEEN IMPLANTED, FOLLOWING THE RECOMMENDATIONS FOR USE. THIS USUALLY OCCURS WITHIN THE 1ST 6 MONTHS POST-OP. THE MOST PROBABLE CAUSE HAS BEEN DETERMINED TO BE CRYSTALLINE LENS TOUCH DURING SURGERY WHICH COULD HAVE BEEN EITHER INSTRUMENTS USED OR THE ICL ITSELF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM120V4 12MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2008 AND LENS OPACITY (ASCO) WAS NOTED ON (B)(6) 2012. THE LENS WAS REMOVED ON (B)(6) 2012, CATARACT SURGERY WAS PERFORMED AND AN IOL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM120V4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention