BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 3290095 · Received August 12, 2013

    Report

    Report Number
    9611165-2013-00077
    Event Type
    Other
    Date Received
    August 12, 2013
    Date of Event
    July 1, 2012
    Report Date
    July 1, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO INDICATION WITHIN THE AVAILABLE INFO THAT ANY REMEDIAL, CORRECTION OR PREVENTIVE ACTION HAS BEEN UNDERTAKEN BY THE HEALTHCARE FACILITY SINCE THE DEPOSITS WERE FIRST OBSERVED IN 2012. RAYNER INTRAOCULAR LENSES LTD HAS REQUESTED ADDITIONAL INFO, INCLUDING A CLINICAL DIAGNOSIS (E.G. DEPOSITS, OPACIFICATION, CALCIFICATION) FROM THE HEALTHCARE FACILITY TO FACILITATE FURTHER INVESTIGATION OF THE REPORTED DEVELOPMENT OF GRANULAR DEPOSITS IN THE ANTERIOR AND POSTERIOR SURFACES OF THE IOL. THE REP IN NEW ZEALAND IS CO-ORDINATING THE F/U WITH THE HEALTHCARE FACILITY AND HAS ADVISED RAYNER THAT TO DATE, NO FURTHER INFO HAS BEEN RECEIVED. IT IS THE INTENTION OF RAYNER UPON RECEIPT OF ANY ADDITIONAL INFO TO CONDUCT AN INTERNAL REVIEW OF THE DATA AND TO FORWARD THE DATA TO A CLINICAL CONSULTANT FOR FURTHER FEEDBACK.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD RECEIVED NOTIFICATION VIA A REP (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYNER TORIC INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT "[THE PATIENT[ HAD BILATERAL "RAYNER TORIC" LENSES IMPLANTED IN 2010 WITH INITIALLY VERY GOOD RESULT. RECENTLY SHE HAD BECOME MORE PHOTOSENSITIVE AND FEELS THAT HER VISION IS NOT AS CLEAR AND EXAMINING HER EYES I WAS INTERESTED TO SEE WHAT SEEMED TO BE VERY FINE REFRACTILE DEPOSITS IN THE ANTERIOR AND POSTERIOR SURFACES OF THE IMPLANTS". IN CORRESPONDENCE WITH THE REP IN (B)(6), THE HEALTHCARE PROFESSIONAL STATED "I FIRST SAW THE CHANGES NINE MONTHS AGO AND THERE HAS BEEN NO SIGNIFICANT DETERIORATION THAT I CAN SEE SINCE THEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387050 UNKNOWN HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1