BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2161869 · Received July 8, 2011

    Report

    Report Number
    2023826-2011-00617
    Event Type
    Injury
    Date Received
    July 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    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). EVAL METHOD: LENS WORK ORDER SEARCH. MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. 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 U.S. 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, (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD A MICL 13.2MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE ON (B)(6) 2006. AS PART OF THE POST MARKET STUDY, THE PT REPORTED DEVELOPING CATARACTS AND LOSS OF VISUAL ACUITY. THE DOCTOR'S OFFICE WAS CONTACTED AND DOCTOR STATED AN ANTERIOR SUBCAPSULAR CATARACT WAS DIAGNOSED ON (B)(6) 2006. THE LENS REMAINS IMPLANTED. PT'S LAST VISIT WAS ON (B)(6) 2010. THE CATARACT HAS NOT PROGRESSED. VISUAL ACUITY 20/70. LOSS OF VISION ACUITY IS FROM MYOPIC MACULOPATHY AND NOT THE CATARACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention