BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2901545 · Received January 4, 2013

    Report

    Report Number
    2023826-2013-00012
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF BOTH PLATE HAPTICS WERE TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE EVENT WAS DUE TO TECHNICAL ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A MICL 13.2MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE. THE LENS FLIPPED DURING INSERTION INTO THE PATIENT'S EYE AND WAS INSERTED UPSIDE DOWN. THE LENS WAS DAMAGED AS THE SURGEON REMOVED THE LENS FROM THE EYE. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS USED. THE REPORTER STATED THE CAUSE OF THIS INCIDENT WAS TOO MUCH VISCOELASTIC WAS USED, CAUSING THE LENS TO UNFOLD IMPROPERLY AND LENS FLIPPING DURING INSERTION INTO THE EYE. THERE WERE TWO LENSES USED ON THE SAME PATIENT AND THE SAME EYE, DURING THE SAME PROCEDURE. THIS REPORT IS FOR THE PRIMARY LENS. SEE MFR #2023826-2013-000 FOR SECONDARY LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4360 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR INJECTOR: MODEL MSI-PF, LOT #UNK| FOAM TIP PLUNGER: MODEL UNK, LOT #UNK| CARTRIDGE: MODEL SFC-45 FP, LOT #UNK