BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1840904 · Received September 15, 2010

    Report

    Report Number
    2023826-2010-00921
    Event Type
    Injury
    Date Received
    September 15, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY. EXPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. PER MEDICAL REVIEW - THE ICL IS INDICATED IN PTS 21-45 YEARS OF AGE. THERE IS A MUCH GREATER RISK OF CATARACT IN PTS OVER 45 YEARS OF AGE POST ICL IMPLANTATION. THE PT IN THIS CASE IS OVER 45 YEARS OF AGE. 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 UNITED STATES FDA CLINICAL TRIALS, APPROX 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 THESE CASES AND VISUAL OUTCOME WAS GOOD. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, THE MOST LIKELY CAUSE OF THE EVENT WAS THE OFF-LABEL USE OF THE LENS WITH THE PT OLDER THAN THE INDICATED AGE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE ICL WAS EXPLANTED ON (B)(6 010. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED. THE PATIENT'S VA WAS 20/20 AND THE PROGNOSIS IS GOOD.

    Description of Event or Problem · 1

    THE PT REPORTED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE (OD) ON (B)(6)2006. THE PT REPORTED HAVING LOST VISION DUE TO THE DEVELOPMENT OF A CATARACT. THE CATARACT WAS DIAGNOSED ON (B)(6)2009 AND WAS A NATURAL SUPERIOR CORTICAL CATARACT. THE ICL REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL AND LOT # UNK| INJECTOR MODEL AND LOT # UNK| FOAM TIP PLUNGER MODEL AND LOT # UNK