BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2112095 · Received June 2, 2011

    Report

    Report Number
    2023826-2011-00487
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - CATARACT, INDUCED, VISION, LOSS OF, DEVICE REMAINS IMPLANTED. EVALUATION METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. 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, A LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE LENS IN REGARDS TO THE PATIENT'S AGE. (B)(4). LENS REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE PATIENT REPORTED THE LENS WAS EXPLANTED AND CATARACT SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE ICL WAS EXPLANTED ON (B)(6) 2013 AND CATARACT SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN HIS LEFT EYE (OS) ON (B)(6) 2008. THE PATIENT REPORTED THE DEVELOPMENT OF A CATARACT. THE FACILITY REPORTED THE CATARACT WAS DIAGNOSED ON (B)(6) 2011. THE PATIENT'S POST-OP VA WAS 20/25. THE ICL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL 12.6

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CARTRIDGE: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK