BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPERIC INTRAOCULAR LENS

    MDR report key: 3072536 · Received April 18, 2013

    Report

    Report Number
    3006723646-2013-00290
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HAPTIC BROKE RIGHT AFTER THE LENS WAS IMPLANTED INTO PT 'S EYE. LENS HAD BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168502 ISERT ASPERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. 231

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention