BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1477024 · Received September 16, 2009

    Report

    Report Number
    3006723646-2009-00003
    Event Type
    Injury
    Date Received
    September 16, 2009
    Date of Event
    August 13, 2009
    Report Date
    September 16, 2009
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC. (HSO) HAS BEEN UNABLE TO CONTACT THE PHYSICIAN DESPITE SEVERAL ATTEMPTS. SINCE HSO IS UNABLE TO CONFIRM THAT THE LENS DID NOT CAUSE A SERIOUS INJURY, WE ARE CLASSIFYING THIS EVENT, FOR THE MOMENT, AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    CAPSULAR BAG RUPTURED DURING IMPLANTATION, LENS EXPLANTED. NO VITRECTOMY REQUIRED.

    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 Required Intervention