BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3945212 · Received July 18, 2014

    Report

    Report Number
    2023826-2014-00538
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER® ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT; (EXPIRED DEVICE IMPLANTED). EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - (NO DEVICE FAILURE): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, IT WAS DETERMINED THAT THERE WAS NO ADVERSE OUTCOME ASSOCIATED WITH THIS PRODUCT. (B)(4) - LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS IN THE PATIENT'S RIGHT EYE ON (B)(6) 2014. THE EXPIRATION DATE ON THE LENS WAS (B)(6) 2013. THE LENS REMAINS IMPLANTED AND NO ADVERSE OUTCOME OR PRODUCT ALLEGATION IS ASSOCIATED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422773 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR