BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3766931 · Received April 2, 2014

    Report

    Report Number
    9611165-2014-00045
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 27, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    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. AS A RESULT OF POSTERIOR CAPSURE RUPTURE, THE HEALTHCARE FACILITY WERE REQUIRED TO PERFORM ADD'L SURGERY TO REMOVE THE LENS FROM THE VITREOUS. RAYNER INTRAOCULAR LENSES LIMITED IS LIAISING WITH THE HEALTHCARE FACILITY TO OBTAIN ADD'L INFO ON THE EVENT. THE HEALTHCARE FACILITY REPORTS THAT THE MEDICEL (B)(4) INJECTOR (LOT: 1193G07) WAS USED TO IMPLANT THE RAYNER IOL SUBJECT TO THIS REPORT. MEDICEL HAS BEEN NOTIFIED OF THE REPORT BY RAYNER INTRAOCULAR LENSES LIMITED. POSSIBLE ROOT CAUSES OF POSTERIOR CAPSULE RUPTURE ARE THE INJECTOR PLUNGER BEING ADVANCED TOO QUICKLY AND THE USER FORCING A JAMMED PLUNGER DURING IOL INSERTION. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE OF THE EVENT AT THIS TIME DUE TO THE LIMITED AMOUNT OF INFO THAT IS AVAILABLE TO RAYNER.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED REC'D NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE HEALTHCARE FACILITY REPORTS THAT THE SURGEON INJECTED THE LENS AND DURING INJECTION HEARD A POPPING SOUND. THE HEALTHCARE PROFESSIONAL STATES THAT THE POSTERIOR CAPSULE RUPTURED DURING INJECTION AND THAT THE LENS WENT INTO THE VITREOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200203 NA HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention