BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1841269 · Received September 14, 2010

    Report

    Report Number
    2023826-2010-00906
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    June 8, 2010
    Report Date
    August 17, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2010. AFTER LENS WAS INSERTED INTO THE EYE, THE SURGEON NOTICED THERE WAS A SMALL PIECE OF HAPTIC MISSING FROM THE LENS. THE SURGEON DECIDED TO LEAVE THE LENS IMPLANTED. THE LENS TEAR DOES NOT INTERFERE WITH THE PATIENT'S VISION. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE LENS TORE DURING DELIVERY. THE LENS REMAINS IMPLANTED. SEE MFR # 2023826-2010-00905 FOR THE RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention FOAM TIP PLUNGER: MODEL - LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP - LOT NUMBER UNK| INJECTOR: MODEL - MSI-PF - LOT NUMBER UNK