BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3535371 · Received October 29, 2013

    Report

    Report Number
    9611165-2013-00105
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    September 30, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    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 LTD. THE HEALTHCARE PROFESSIONAL REPORTS THAT WHEN SUCH INCIDENCES OCCUR THE STABILITY AND CENTRALITY OF THE IOL IS FIRST CHECKED AND IF FOUND TO BE ACCEPTABLE THE IOL IS LEFT IN PLACE. IF THE IOL IS FOUND NOT TO BE STABLE OR CENTRAL IT IS EXPLANTED FROM THE EYE AND EXCHANGED. THE HEALTHCARE FACILITY HAS NOT CONFIRMED WHICH ACTION WAS CARRIED OUT IN THIS CASE. THE HEALTHCARE FACILITY HAS CONFIRMED THAT NO FURTHER REMEDIAL ACTION IS REQUIRED AND THAT THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT. THE HEALTHCARE PROFESSIONAL DESCRIBES THE CONDITION OF THE PATIENT POST-OPERATIVELY AS "FINE AND HAPPY." IN THE ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL RAYNER WERE ADVISED THAT IN CASES WHERE RESISTANCE IS EXPERIENCED DURING INJECTION THE LENS IS INJECTED OUT INTO A GALLIPOT AND IS THEN RELOADED. RAYNER DEVICES ARE SINGLE-USE ONLY AND THIS ACTION IS A DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU). RAYNER IFU CONTAIN THE FOLLOWING STATEMENTS "EXCESSIVE RESISTANCE COULD INDICATE A TRAPPED LENS" AND "IF THE IOL CAUSES A BLOCKAGE IN THE INJECTOR SYSTEM, DISCARD THE INJECTOR."

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(4) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE IOL HAPTIC BROKE DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555777 UNK HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1