BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2981624 · Received February 27, 2013

    Report

    Report Number
    2023826-2013-00165
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. MALPOSITION OF DEVICE. DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON LOADED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS AND UPON INSERTION, THE LENS FLIPPED UPSIDE DOWN IN THE PATIENT'S EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACK-UP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84007 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK