BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 3111341 · Received May 9, 2013

    Report

    Report Number
    3006723646-2013-00293
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS ENDOPHTHALMITIS. THE DOCTOR DOES NOT APPEAR TO BELIEVE THE EVENT IS LENS RELATED AT THIS TIME. THE EXPIRATION DATE OF THE LENS IS 31-AUG-2015. THE COMPANY HAS BEEN ATTEMPTING TO GET MORE INFO FROM THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202809 ISYMM ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FY-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention