BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 2823635 · Received October 31, 2012

    Report

    Report Number
    9611165-2012-00062
    Event Type
    Other
    Date Received
    October 31, 2012
    Report Date
    September 10, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS INCIDENT BY RAYNER INTRAOCULAR LENSES LIMITED. ALL RAYNER CAPSULAR BAG FIXATED INTRAOCULAR LENSES ARE MANUFACTURED FROM HYDROPHILIC ACRYLIC (COMMONLY REFERRED TO AS RAYACRYL). IT IS THEREFORE, POSSIBLE FOR THE REPORTED EVENT TO OCCUR ON THE C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES, WHICH ARE AVAILABLE IN THE UNITED STATES OF AMERICA. WITHOUT THE ABILITY TO EXAMINE THE PRODUCT 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 THE (B)(6) DISTRIBUTOR OF A SUSPECTED CAUSE OF CALCIFICATION ON (B)(6) 2012. THE EVENT DESCRIPTION PROVIDED STATES THAT CALCIFICATION DEVELOPED POST-OPERATIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1