BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1963462 · Received January 11, 2011

    Report

    Report Number
    2023826-2011-00039
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)OTHER (LENS FLIPPED AND INSERTED UPSIDE DOWN). EVAL: METHOD (OTHER): LENS WORK ORDER SEARCH. RESULTS (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED AS A 13.7 MM MICL 13.7 IMPLANTABLE COLLAMER LENS WAS BEING LOADED, THE LENS TORQUED AND UPON INSERTION, THE LENS FLIPPED AND WAS INSERTED UPSIDE DOWN. THE LENS HAPTIC WAS TORN WHILE BEING REMOVED, WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACKUP ICL 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. MICL 13.7 NA

    Patients

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