BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 1625639 · Received February 19, 2010

    Report

    Report Number
    3006723646-2010-00006
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    December 28, 2009
    Report Date
    February 20, 2010
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC. IS REQUESTED FOR MORE INFORMATION REGARDING THE PATIENT'S INITIALS.

    Description of Event or Problem · 1

    THE IOL WAS EXPLANTED WHEN THE HAPTIC TORE OFF. PATIENT'S PROGNOSIS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention