BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2862944 · Received December 10, 2012

    Report

    Report Number
    2023826-2012-00972
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND THERE WAS NO VISIBLE DAMAGE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SURGEON INSERTED THE MICL12.6 IMPLANTABLE COLLAMER LENS IN THE EYE THE LENS FLIPPED UPSIDE DOWN. THE SURGEON REMOVED THE LENS FROM THE EYE AND ATTEMPTED TO RELOAD IT BUT DROPPED IT ON THE FLOOR AND CONTAMINATED IT. THEREFORE, THE BACK-UP LENS WAS IMPLANTED. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A LOADING ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR