BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 2934842 · Received January 23, 2013

    Report

    Report Number
    3006723646-2013-00275
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 22, 2013
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED THAT DUE TO COMPROMISED STRUCTURES IN THE EYE THAT THE LENS WAS REMOVED AND A DIFFERENT TYPE OF LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33245 ISYMM ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FC-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention