BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 4385960 · Received April 10, 2014

    Report

    Report Number
    3003563511-2014-00046
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    March 27, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED REPORTS THE FOLLOWING INVESTIGATION: OUR REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX ASPHERIC 920H IOL BATCH 090E14570 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SUPERFLEX ASPHERIC 920H IOL CONFIRMED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE SUPERFLEX ASPHERIC 920H IOL BATCH 090E14570.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION VIA ITS (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE DISTRIBUTOR REPORTS THAT THEY RECEIVED NOTIFICATION OF THE DEVELOPMENT OF OPACIFICATION IN THE OD AND OS EYES OF A PT IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFO, PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00046. INFO ON THE REPORT OF OPACIFICATION IN THE OS EYE CAN BE FOUND IN MDR 3003563511-2014-0047 AND RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219866 SUPERFLEX ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED 920H 090E14570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention