BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4182812 · Received October 17, 2014

    Report

    Report Number
    2023826-2014-00828
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    October 1, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: 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

    RECEIVED FORM FDA 3500A MEDWATCH FROM USER FACILITY ((B)(4)) - THE REPORTER INDICATED THE PATIENT UNDERWENT UNEVENTFUL ICL SURGERY ON (B)(6) 2014 OU. THE PATIENT PRESENTED EIGHT DAYS POST-OP WITH CELLS AND FLARE OS. THE PATIENT STATED VISION WOULD BE BLURRY FIRST THING IN THE MORNING BUT WOULD CLEAR. INCREASED STEROID AND ANTIBIOTIC. REFERRED TO RETINAL SURGEON (B)(6) 2014 BECAUSE SYMPTOMS WERE NOT RESOLVING. RETINAL SURGEON CULTURED OS AND INJECTED ANTIBIOTIC AND STEROID OS. NO GROWTH AT 48 AND 72 HOURS. VA CONTINUED TO BE 20/20 OS AT ALL VISITS. ON (B)(6) 2014, PATIENT PRESENTED COMPLAINING OF PAIN AND SIGNIFICANT DECREASE IN VISION OS. PRESSURE WAS 45 OS. PATIENT DIAGNOSED WITH ANGLE CLOSURE EVENT. PILO GTTS X 2, 250MG X2 DIAMOX TABS PO GIVEN, PI ENLARGED. PATIENT STAYED AT THE CENTER, PRESSURE DROPPED, CORNEA BEGAN TO CLEAR. PATIENT WAS DISCHARGED WHEN STABLE. RECHECK NEXT DAY, VA 20/25 OS, PAIN GONE. PATIENT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662266 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK