BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2970051 · Received February 20, 2013

    Report

    Report Number
    2023826-2013-00141
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 29, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT . FAILURE TO EXPAND. DIFFICULT TO FOLD OR UNFOLD. DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. AFTER INJECTING THE ICL INTO THE ANTERIOR CHAMBER, THE FOOTPLATES STUCK TO EACH OTHER SO THE LENS DID NOT UNFOLD. THE ICL WAS REMOVED, RELOADED AND INJECTED A SECOND TIME. THE ICL WAS THEN FOUND TO BE TURNED UPSIDE DOWN, AND THE ICL WAS REMOVED. THE LENS WAS EXCHANGED FOR ANOTHER SAME MODEL LENS WHICH RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73366 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR INJECTOR MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE MODEL AND LOT NUMBER UNKNOWN