BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4103556 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00746
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES: METHOD - (OTHER): WORK ORDER SEARCH RESULTS - (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS -(NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS IMPLANTED.

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REPORTEDLY, BY A PATIENT ON THE 60-MONTH ICL FOLLOW-UP FORM, MYOPIC CHOROIDAL NEOVASCULAR MEMBRANE WAS FOUND IN (B)(6) 2013 AND SHE WAS MEDICALLY TREATED (AVASTIN ) EVER SINCE. ACCORDING TO THE DCR, DATED ON 9/23/2014, THE NEOVASCULAR MEMBRANE WAS NOT RELATED TO THE DEVICE BUT TO THE PATIENT PRE-EXISTING CONDITION (CHRONIC MYOPIA). PATIENT WAS UNDER TREATMENT BY RETINA SPECIALIST AND PROGNOSIS WAS GOOD/STABLE. LENS REMAINS IMPLANTED. THE SURGEON ATTRIBUTED BEST CORRECTED VISUAL ACUITY OF 20/40 TO THE PATIENT FACTOR (CHRONIC MYOPIA). MYOPIC EYES ARE KNOWN TO HAVE LONGER AXIAL LENGTHS AND VITREOUS CHAMBER DEPTHS COMPARED TO EMMETROPIC EYES. SUCH ELONGATION MAY LEAD TO MECHANICAL STRETCHING AND THINNING OF THE CHOROID AND RETINAL PIGMENT EPITHELIUM INCLUDING VASCULAR CHANGES. ONE OF THESE CHANGES IS CHOROIDAL NEOVASCULAR MEMBRANE WHICH COULD BE A SIGHT-THREATENING COMPLICATION THAT OCCURS IN UP TO 10% OF PATHOLOGICAL MYOPIA. IT SHOULD BE NOTED THAT AT THE TIME OF THE SURGERY (2009) THE PATIENT WAS (B)(6) AND PER DFU, VISIAN ICL IS INDICATED FOR ADULTS 21-45 YEARS OF AGE, AND THEREFORE, THERE IS NO SUFFICIENT DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS . GIVEN ALL THIS INFORMATION PATIENT RELATED FACTORS (CHRONIC EYE CONDITION COMBINED WITH AGE) HAVE CAUSED THE REPORTED EVENT . CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, A PROBABLE CAUSE OF THE EVENT IS PATIENT RELATED FACTORS (CHRONIC EYE CONDITION COMBINED WITH AGE). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN HER RIGHT EYE (OD). THE PATIENT REPORTED HAS BEEN TAKING AVASTIN SHOTS SINCE (B)(6) 2013 DUE TO A MYOPIC CHOROIDAL NEOVASCULAR MEMBRANE. THE ICL WAS IMPLANTED ON (B)(6) 2009 AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585010 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention