BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 4360597 · Received April 2, 2014

    Report

    Report Number
    9611165-2014-00046
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Report Date
    March 26, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. FOLLOWING CATARACT SURGERY ON (B)(6) 2011 THE PATIENT UNDERWENT A NUMBER OF ADDITIONAL SURGICAL PROCEDURES. THE PATIENT WAS REQUIRED TO UNDERGO A SECOND TRABECULECTOMY AND MMC PROCEDURE AND WAS REHOSPITALISED SIX TIMES IN THE SECOND HALF OF 2013 FOR NEEDLING+5-FU+FORTECORTIN PROCEDURES. PLEASE REFER TO THE ATTACHED DOCUMENT FOR FURTHER INFO. THE PATIENT SUFFERS FROM GLAUCOMA AND RAYNER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO ASCERTAIN WHETHER GLAUCOMA IS CHRONIC. ADDITIONAL INFO ON THE PATIENT'S COURSE OF TREATMENT IS ALSO BEING REQUESTED. REMEDIAL, CORRECTIVE AND PREVENTATIVE ACTION WILL BE TAKEN BY THE HEALTHCARE FACILITY. THE HEALTHCARE FACILITY PLAN TO EXPLANT THE SUPERFLEX ASPHERIC 920H IOL. THE SUPERFLEX ASPHERIC 920H IOL WILL BE EXCHANGED FOR A RETROPUPILLAR IRIS CLAW LENS. THE HEALTHCARE FACILITY INTENDS TO SEND HALF OF THE IOL TO RAYNER IOL FOR ANALYSIS. THE HEALTHCARE FACILITY WILL RETAIN THE SECOND HALF AND WILL CARRY OUT THEIR OWN ANALYSIS. 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.

    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 PATIENT IN THE POST-OPERATIVE PERIOD. FOR INFO ON THE REPORTED OPACIFICATION OF THE IOL IMPLANTED IN THE OS EYE PLEASE REFER TO RAYNER'S MDR 9611165-2014-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200514 SUPERFLEX ASPHERIC HQL-INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 920H 090E14570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention