BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 5932980 · Received December 10, 2014

    Report

    Report Number
    3003563511-2014-00086
    Event Type
    Injury
    Date Received
    December 10, 2014
    Report Date
    December 10, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 ASPHERIC 920H IOL. THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES "THIS MAN IS (B)(6) Y/O, 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." FOR FURTHER INFO, PLEASE REFER TO RAYNER'S MDR 9611165-2014-00086.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804267 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 920H 097E76109

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention