BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 3913895 · Received May 8, 2014

    Report

    Report Number
    3003563511-2014-00053
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 27, 2013
    Report Date
    March 28, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES REPORTS THE FOLLOWING INVESTIGATION FINDINGS: OUR REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX ASPHERIC 920H IOL BATCH 089E93312 SHOWED THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE W/O DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SUPERFLEX ASPHERIC 920H IOL (AUGUST 2009) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN REC'D AGAINST THE SUPERFLEX ASPHERIC 920H IOL BATCH 089E93312.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE DEVELOPMENT OF OPACIFICATION WAS OBSERVED ON (B)(6) 2013. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278102 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 920H 089E93312

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention GENTAMYCINE DROPS| DEXAMETHASONE