BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 3111322 · Received May 9, 2013

    Report

    Report Number
    3006723646-2013-00296
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 11, 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 (B)(6) 2015. THE COMPANY HAS BEEN ATTEMPTING TO GET MORE INFORMATION FROM THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204950 ISYMM ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FY-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention