BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX ADVANCE ASPHERIC

    MDR report key: 4120857 · Received September 24, 2014

    Report

    Report Number
    3003563511-2014-00066
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 7, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER REPORTS THE FOLLOWING INVESTIGATION FINDINGS: OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX ADVANCE ASPHERIC ADV970 IOL (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 MOTHER OF MANUFACTURE OF THE C-FLEX ADVANCE ASPHERIC ADV970 IOL ((B)(4)) WAS CARRIED OUT IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDES THAT NO OTHER REPORTS, OF ANY NATURE, HAVE BEEN RECEIVED AGAINST THE C-FLEX ASPHERIC ADVANCE ADV970 IOL (B)(4) .

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(4) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A C-FLEX ADVANCE ASPHERIC ADV970 INTRAOCULAR LENS (IOL). THE HEALTHCARE PROFESSIONAL REPORTS THAT A CUT WAS OBSERVED ON THE LENS OPTIC FOLLOWING IMPLANTATION OF THE LENS INTO THE EYE. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00066.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595289 C-FLEX ADVANCE ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED ADV970 034E57182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention