BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1963528 · Received January 12, 2011

    Report

    Report Number
    2023826-2011-00041
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 21, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - LENS WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC BROKEN. THE LENS WAS RETURNED DRY. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY , WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED A 13.2 MM VICM 13.2 IMPLANTABLE COLLAMER LENS WAS RECEIVED BROKEN. THE LENS WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. VICM 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR CARTRIDGE: MODEL AND LOT # UNK| INJECTOR: MODEL AND LOT # UNK| FOAM TIP PLUNGER: MODEL AND LOT # UNK