BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1841258 · Received September 15, 2010

    Report

    Report Number
    2023826-2010-00923
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 16, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE. THE PATIENT'S EYE MOVED AS THE SURGEON ATTEMPTED TO INSERT THE LENS. THE SURGEON DECIDED TO TRY AGAIN AND INSERTED THE LENS USING FORCEPS. THE LENS TORE AND WAS REMOVED. THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR CARTRIDGE: MODEL SFC-45 FP - LOT NUMBER - UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL MSI-PF - LOT NUMBER - UNK