BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1870104 · Received October 5, 2010

    Report

    Report Number
    2023826-2010-01013
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    June 1, 2009
    Report Date
    September 14, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL CODES, METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND. 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

    RESULTS: MEDICAL REVIEW - THE ICL IS INDICATED IN PATIENTS 21-45 YEARS OF AGE. THERE IS A MUCH GREATER RISK OF CATARACT IN PATIENTS OVER 45 YEARS OF AGE POST ICL IMPLANTATION. THE PATIENT 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 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 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 IS THE OFF-LABEL USE OF THE ICL.

    Description of Event or Problem · 1

    THE PT REPORTED THE SURGEON IMPLANTED A 12.6 MM MICL12.6 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 ICL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE CATARACT WAS DIAGNOSED ON (B)(6) 2009. THE CATARACT HAS NOT PROGRESSED AND THE ICL REMAINS IMPLANTED. THE PATIENT'S CURRENT VA IS 20/25 AND THE PROGNOSIS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention CARTRIDGE: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK