BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2002614 · Received February 7, 2011

    Report

    Report Number
    2023826-2011-00107
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (LENS FLIPPED AND INSERTED UPSIDE DOWN). METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2011. THE LENS FLIPPED DURING INSERTION AND WAS INSERTED INTO THE EYE UPSIDE DOWN. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION AND NO SUTURE. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER: UNK| FORM TIP PLUNGER MODEL, LOT NUMBER: UNK| INJECTOR: MODEL - MSI-PF, LOT NUMBER: UNK