BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1531234 · Received November 12, 2009

    Report

    Report Number
    2023826-2009-01240
    Event Type
    Injury
    Date Received
    November 12, 2009
    Report Date
    December 4, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY SURGERY - INCISION SUTURED - GLARE, ASTIGMATISM - IRIS TRAUMA. RESULTS - A WORK ORDER SEARCH WAS CONDUCTED AND THERE WAS NO SIMILAR COMPLAINTS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MICL 12.6 IMPLANTABLE COLLAMER LENS IMPLANTED IN THE RIGHT EYE IN 2006. AS PART OF THE STUDY, THE PATIENT REPORTED SHE HAD DEVELOPED A CATARACT AND HAD DIFFICULTY WITH LIGHTS AND NIGHT VISION. THE SURGEON'S OFFICE WAS CONTACTED IN 2009. THE CATARACT WAS DIAGNOSED IN 2008, THE CATARACT HAD PROGRESSED. IN 2009, THE ICL WAS EXPLANTED, IRIS TORN DURING SURGERY AND THREE SUTURES WERE NEEDED. ICL WAS EXCHANGED FOR AN IOL. THE PATIENT WAS LAST SEEN IN THE SAME MONTH. THE DOCTOR HAD NOTED SUPERIOR TEMPORAL ISCHEMIA ON IRIS DURING CATARACT SURGERY. THERE WAS TRAUMA AND INDUCED ASTIGMATISM. NEXT POST-OP VISIT SCHEDULED FOR 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNKNOWN| INJECTOR: MODEL - UNKNOWN AND LOT NUMBER - UNKNOWN| CARTRIDGE: MODEL - UNKNOWN AND LOT NUMBER - UNK