BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2821677 · Received November 6, 2012

    Report

    Report Number
    2023826-2012-00883
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS FLIPPED. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID. A PIECE OF A HAPTIC WAS TORN OFF AND MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE SURGEON INSERTED THE MICL13.2 IMPLANTABLE COLLAMER LENS IT FLIPPED UPSIDE DOWN. THE LENS WAS TORN AS IT WAS REMOVED FROM THE EYE AND THE BACK UP LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A USER'S ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NAVIJECT INJECTION SYSTEM: LOT NUMBER UNKNOWN