BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 1724293 · Received June 4, 2010

    Report

    Report Number
    3006723646-2010-00041
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HSO IS ATTEMPTING TO GET PATIENT INITIALS FROM THE FACILITY. LENS WAS REMOVED FROM THE EYE WITH NO INJURY/COMPLICATION FOR THE PATIENT.

    Description of Event or Problem · 1

    LENS WAS EXPLANTED WHEN A HAPTIC BROKE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PC-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention