BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 4359856 · Received December 16, 2014

    Report

    Report Number
    9611165-2014-00086
    Event Type
    Injury
    Date Received
    December 16, 2014
    Report Date
    December 10, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PATIENT HAS DEVELOPED A PUNCTATE DEPOSIT OVER THE ANTERIOR IOL SURFACE. THE DEPOSIT IS CONFINED TO THE PUPIL AND THE IOL MATERIAL IS REPORTED TO OTHERWISE APPEAR CLEAR. THE HEALTHCARE PROFESSIONAL REPORTS "THE ANTERIOR SEGMENT SHOWS NO SIGN OF ACTIVE OR CHRONIC UVEITIS AND PRESSURE IS 14. FUNDUS VIEW IS HAZY BUT THERE IS NO SIGN OF INFLAMMATION OR RETINAL PATHOLOGY". IT IS NOT YET KNOWN WHAT CORRECTIVE ACTION WILL BE UNDERTAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PUNCTATE DEPOSIT. RAYNER IS LIAISING WITH THE HEALTHCARE PROFESSIONAL VIA ITS DISTRIBUTOR TO OBTAIN ADDITIONAL INFORMATION TO FACILITATE FURTHER INVESTIGATION OF THE REPORTED INFORMATION. THE INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL TO DATE AND ANY SUPPLEMENTARY INFORMATION RECEIVED WILL BE SENT TO A CLINICAL CONSULTANT FOR REVIEWS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SUPERFLEX ASPHERIC 920H IOL ((B)(6) 2007) WAS CARRIED OUT IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, IF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE SUPERFLEX ASPHERIC 920H IOL BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING THE IMPLANTATION OF A SUPERFLEX ASPERIC 920H IOL. THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES "THIS MAN IS (B)(6), HIS FELLOW EYE HAS OLD TRAUMA WITH LIMITED POTENTIAL FOR VISION. THE EYE IN QUESTION HAD MACULAR HOLE SURGERY IN EARLY 2009, VITY+GAS...HE RAPIDLY DEVELOPED A SEVERE PSC CATARACT AND THIS WAS OPERATED IN (B)(6) 2009. UNCOMPLICATED SURGERY WITH RAYNER 920H +19.0D...POST-CATARACT SURGERY THE HOLE WAS FOUND TO BE OPEN AND HE HAD A REPEAT PROCEDURE WITH GOOD RESULT AND 6/15 ACUITY. CAPSULE OPACIFICATION THEN OCCURRED AND THIS WAS YAG'D, FINAL ACUITY WAS 6/9. HE HAS NOW RETURNED WITH ACUITY OF 6/30...HE'D DEVELOPED A PECULIAR PUNCTATE DEPOSIT OVER THE ANTERIOR IOL SURFACE, CONFINED TO THE AREA EXPOSED BY THE PUPIL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825286 SUPERFLEX ASPHERIC HQL RAYNER INTRAOCULAR LENSES LTD. 920H` 097E76109

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention