BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2162468 · Received July 14, 2011

    Report

    Report Number
    2023826-2011-00629
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    June 14, 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): EVALUATION CODES: LENS WORK ORDER SEARCH. 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 REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD/RESULTS: MEDICAL REVIEW - GLAUCOMA MOST OFTEN OCCURS IN ADULTS OVER (B)(6) WITH A FAMILY HISTORY OF GLAUCOMA. THERE IS AN INCREASED RISK IN PEOPLE WHO ARE HIGHLY MYOPIC, HAVE DIABETES, AND THOSE TAKING CORTICOSTEROIDS. THE SURGEON STATED THAT THE TYPE OF GLAUCOMA IS OPEN ANGLE, AND NOT CAUSED BY THE DEVICE ITSELF, BUT DUE TO THE PATIENT BEING HIGHLY MYOPIC. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS IN HIS RIGHT EYE (OD) ON (B)(6) 2007. THE PATIENT REPORTED HE WAS PRESCRIBED EYE DROPS FOR AT LEAST THREE MONTHS DUE TO HIGH PRESSURE OR GLAUCOMA IN THE EYE. 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 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK