BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 2945081 · Received February 1, 2013

    Report

    Report Number
    9611165-2013-00007
    Event Type
    Other
    Date Received
    February 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. THE HEALTHCARE PROFESSIONAL INTENDS TO PERFORM A YAG CAPSULOTOMY. NO FURTHER INFO ON THE PROPOSED CORRECTIVE ACTION AND/OR THE RESULTS OF THIS ACTION HAS BEEN PROVIDED TO RAYNER. RAYNER SOUGHT CLINICAL FEEDBACK FROM THE CLINICAL ADVISORY TEAM ON THE REPORTED EVENT AND RECEIVED THE FOLLOWING RESPONSE; "ANY BSS LEFT BEHIND AN IOL WILL RAPIDLY BE REPLACED BY AQUEOUS. MY EXPERIENCE IS THAT AS THE CAPSULE CONTRACTS (OVER A FEW WEEKS MAXIMUM) THIS POTENTIAL SPACE DISAPPEARS EXCEPT WHEN THE SURGEON LEAVES OVD BEHIND THE IOL. IF THE IOL BLOCKS THE CAPSULORRHEXIS, THEN YOU HAVE THE SCENARIO FOR CAPSULAR BLOCK SYNDROME, AND THE OVD WILL DEGRADE AND BECOME CLOUDY. THIS WOULD EXPLAIN WHY THIS SURGEON IS HAVING A SERIES OF CASES; SHE IS NOT USING THE "ROCK AND ROLL" MANEUVER INTRAOPERATIVELY TO DISPLACE OVD FOR BEHIND THE IOL." 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 THE (B)(6) REP OF AN EVENT THAT OCCURRED FOLLOWING THE IMPLANTATION OF A RAYNER INTRAOCULAR LENS (MODEL NUMBER UNK). THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE HEALTHCARE PROFESSIONAL HAS REPORTED A SYMPTOMATIC REDUCTION IN THE QUALITY OF VISION OF A PT POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45226 UNK HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention