BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 4073243 · Received June 20, 2014

    Report

    Report Number
    3006723646-2014-00352
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LENS INSERTOR WAS CRACKED AND DOCTOR DID NOT NOTICE UNTIL HE WAS IN THE PROCESS OF INSERTING THE LENS INTO PTS EYE. LENS HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363317 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. 231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention