BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1578591 · Received December 18, 2009

    Report

    Report Number
    3006723646-2009-00015
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    August 3, 2009
    Report Date
    December 3, 2009
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY WAS PERFORMED ON (B)(6), 2009, BUT HOYA SURGICAL OPTICS, INC. (HSO) WAS ONLY INFORMED OF THE ADVERSE EVENT BY (B)(4), A DISTRIBUTOR, ON (B)(6), 2009. HSO HAS INITIATED COMMUNICATIONS WITH THE DISTRIBUTOR TO RESOLVE THIS ISSUE AND WILL REQUIRE THE DISTRIBUTOR TO INFORM HSO OF SUCH OCCURRENCES WITHIN TWO (2) BUSINESS DAYS.

    Description of Event or Problem · 1

    LENS EXPLANTED WHEN LEADING HAPTIC BROKE. INCISION WOUND WAS SLIGHTLY ENLARGED TO REMOVE LENS, PATIENT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISYMM ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FY-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention