BEUDAMED
    FDA Adverse Event Other Summary report: N

    HQL - INTRAOCULAR LENS

    MDR report key: 3529996 · Received December 4, 2013

    Report

    Report Number
    9611165-2013-00117
    Event Type
    Other
    Date Received
    December 4, 2013
    Report Date
    October 24, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. RAYNER INTRAOCULAR LENSES LIMITED HAS REQUESTED SPECIFIC INFORMATION ON THE SURGICAL PROCEDURES (IOL IMPLANTATION AND YAG CAPSULOTOMY) AND DETAILED PATIENT HISTORY TO AID THE INVESTIGATION OF THE REPORTED OCCURRENCE OF OPACIFICATION. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. THE SLIT LAMP PHOTOGRAPHS SUPPLIED TO RAYNER BY THE DISTRIBUTOR WERE FORWARDED TO A CLINICAL CONSULTANT FOR REVIEW. THE FEEDBACK RECEIVED ON THE IMAGES IS AS FOLLOWS "IT SEEMS THAT THE WHITE MEMBRANE SEEN IS ON THE SURFACE OF THE LENS AND NOT IN THE SUBSTANCE OF THE LENS. THIS IS MOST LIKELY A FIBRIN MEMBRANE WHICH HAS DEVELOPED FOLLOWING YAG CAPSULOTOMY. IF THIS IS THE CASE THEN IT SHOULD SLOWLY RESPOND TO FREQUENT TOPICAL STEROID AND CYCLOPLEGIC DROPS...I COULD NOT SEE ANY OPACIFICATION OF THE LENS IMPLANT." THE CLINICAL CONSULTANT FEEDBACK HAS BEEN FORWARDED TO THE DISTRIBUTOR AND WE ARE CURRENTLY AWAITING THEIR RESPONSE.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATION FOLLOWING ND: YAG CAPSULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629801 HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1