BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1457686 · Received August 28, 2009

    Report

    Report Number
    3006723646-2009-00002
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    May 19, 2009
    Report Date
    August 28, 2009
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC. (HSO) TRIED TO CONTACT THE PHYSICIAN ON 8/6/2009, REPORTER, BUT HE WAS ON VACATION TILL 8/18/2009. HOYA SURGICAL OPTICS, INC, (HSO) TRIED TO CONTACT REPORTER ON 8/19/2009 AND 8/28/2009, BUT WAS UNABLE TO REACH HIM. SINCE HSO IS UNABLE TO CONFIRM THAT THE PT DID NOT SUFFER A SERIOUS INJURY, WE ARE CLASSIFYING THIS COMPLAINT AT SERIOUS INJURY. THOUGH THE EVENT OCCURRED APPROX THREE MONTHS EARLIER, HSO WAS MADE NOT AWARE OF THE COMPLAINT TILL 8/03/2009 BECAUSE OUR FIELD DISTRIBUTOR, DID NOT INFORM HSO. THERE IS A STANDING REQUIREMENT IN THE CONTRACT WITH DISTRIBUTOR TO REPORT SUCH INCIDENTS WITHIN TWO (2) DAYS. HSO HAS SPOKEN WITH DISTRIBUTOR TO ENSURE THAT THIS DOES NOT HAPPEN AGAIN.

    Description of Event or Problem · 1

    THE LEADING HAPTIC DETACHED FROM THE OPTIC DURING IMPLANTATION AND WAS EXPLANTED FROM THE EYE.

    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 73 YR Required Intervention