BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 3659747 · Received November 18, 2013

    Report

    Report Number
    9611165-2013-00109
    Event Type
    Other
    Date Received
    November 18, 2013
    Report Date
    October 17, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. RAYNER INTRAOCULAR LENSES LIMITED MADE CONTACT WITH THE HEALTHCARE PROFESSIONAL TO OBTAIN ADDITIONAL INFORMATION ON THE DEVELOPMENT OF POSTERIOR CAPSULE OPACIFICATION AND WAS ADVISED BY THE SALES SPECIALIST THAT THE HEALTHCARE PROFESSIONAL WOULD NOT BE PROVIDING ANY FURTHER INFORMATION ON THE CASE. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED, A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(4) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION RECEIVED STATES THAT IOL WAS EXPLANTED DUE TO THE DEVELOPMENT OF POSTERIOR CAPSULE OPACIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597481 UNKNOWN HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention