BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2113836 · Received May 17, 2011

    Report

    Report Number
    2023826-2011-00410
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS INSERTING THE MICL13.2 IMPLANTABLE COLLAMER LENS AND THE LENS UNFOLDED AND FLIPPED UPSIDE DOWN. THE LENS WAS REMOVED IMMEDIATELY LENS AND THE BACK UP LENS WAS IMPLANTED. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF THE LENS NOT BEING PROPERLY ALIGNED IN THE INJECTION SYSTEM DURING LOADING.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR CARTRIDGE: MODEL SFC-45FP, LOT NUMBER UNK| INJECTOR: MODEL UNK, LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL, LOT NUMBER UNK