BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX

    MDR report key: 3346748 · Received September 5, 2013

    Report

    Report Number
    3003563511-2013-00036
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 30, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LTD. REPORTS THE FOLLOWING INVESTIGATION FINDINGS: OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX 570C IOL BATCH (B)(4) 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 C-FLEX 570C IOL (MAY 2012) 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 C-FLEX 570C IOL BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD. RECEIVED NOTIFICATION FROM THE (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING USE OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE HAPTIC RUPTURED DURING INJECTION. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT 9611165-2013-00083.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440466 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 570C 052E37609

    Patients

    Seq Age Sex Outcome Treatment
    1