BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1934151 · Received December 8, 2010

    Report

    Report Number
    3006723646-2010-00135
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 8, 2010
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED BECAUSE A HAPTIC BROKE OFF DURING LENS INSERTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention