BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 3303105 · Received August 16, 2013

    Report

    Report Number
    9611165-2013-00079
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    March 28, 2012
    Report Date
    August 5, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. THE REPORTING HEALTHCARE PROFESSIONAL HAS ADVISED RAYNER THAT OPACIFICATION IS LOCATED TO THE IOL OPTIC AND THAT THE PT'S CURRENT VISUAL ACUITY IS PERCEPTION OF LIGHT. THE SUPERFLEX ASPHERIC 920H IOL SUBJECT TO THIS REPORT WAS EXPLANTED ON (B)(6) 2013. RAYNER HAS LIAISED WITH A THIRD PARTY INDEPENDENT LAB IN ORDER TO OBTAIN A CLINICAL EXPLANATION AS TO WHY 'OPACIFICATION' HAS PRESENTED ITSELF IN THE SUPERFLEX ASPHERIC 920H IOL POST DSAEK SURGERY. THE LAB HAS GIVEN THE FOLLOWING HYPOTHETICAL EXPLANATION, "BECAUSE THE OPACIFICATIONS ARE OFTEN LOCALIZED IN THE PUPILLARY AREA OF THE IOL'S MIGHT BE AFFECTED BY THE GAS BUBBLE IN SUCH A WAY THAT THE DEVELOPMENT OF A CRYSTALLIZATION NUCLEUS IS PROMOTED. THE ALTERED BLOOD-AQUEOUS BARRIER MIGHT CO-ACT TO TRIGGER SECONDARY IOL CALCIFICATION." OUR REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX ASPHERIC 920H IOL BATCH 050A11298 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 DEFECT. THE SUPERFLEX ASPHERIC 920H IOL HAS BEEN SENT TO A THIRD PARTY INDEPENDENT LAB FOR ANALYSIS. THE RESULTS OF THE ANALYSIS PERFORMED WILL BE PROVIDED IN A FOLLOW-UP REPORT. OTHER REMARKS: A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SUPERFLEX ASPHERIC 920H IOL (MAY 2010) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE SUPERFLEX ASPHERIC 920H IO. BATCH 050E11298. THE SUPERFLEX ASPHERIC 920H IOL IS NOT AVAILABLE ON THE MARKET IN THE UNITED STATES OF AMERICA; HOWEVER, IS MANUFACTURED FROM THE SAME MATERIAL (HYDROPHILIC ACRYLIC) AS THE C-FLEX 570C AND C-FLEX ASPHERIC 970C IOL'S WHICH ARE AVAILABLE ON THE MARKET IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION OF AN INCIDENT THAT OCCURRED IN A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL) POST DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) SURGERY. THE EVENT DESCRIPTION PROVIDED STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED OPACIFICATION OF THE IOL ON (B)(6) 2012, FIVE MONTHS AFTER, THE PT UNDERWENT A SECONDARY GRAFT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395551 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 920H 050E11298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention