BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4233300 · Received November 6, 2014

    Report

    Report Number
    2023826-2014-00943
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    January 31, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK. EXPLANT DATE: NA. (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS IMPLANTED. METHOD: WORK ORDER SEARCH. RESULTS: 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS IN THEIR LEFT EYE (OS). THE PATIENT REPORTED HAD LOST VISION DUE TO THE DEVELOPMENT OF A CATARACT. THE LENS WAS IMPLANTED ON (B)(6) 2012 AND REMAINS IMPLANTED. THE FACILITY REPORTED THE DATE OF THE CATARACT DIAGNOSIS WAS (B)(6) 2014. THE FACILITY REPORTED THE CATARACT WAS AN ANTERIOR CORTICAL AND THEY FELT THE EVENT WAS NOT DEVICE RELATED. THE CATARACT HAS NOT PROGRESSED AND THE VA WAS 20/25. THE PATIENT HAD LRI SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713240 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR