BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX ADVANCE ASPHERIC

    MDR report key: 4340664 · Received December 11, 2014

    Report

    Report Number
    9611165-2014-00084
    Event Type
    Other
    Date Received
    December 11, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REF (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PT INITIALLY PRESENTED WITH SYMPTOMS OF VISUAL DISTURBANCES. CELLS +++ REACTION WAS OBSERVED 8 DAYS POST-OPERATIVELY. THE PT WAS PRESCRIBED TOPICAL AND SUBTENONAL CORTICOIDS AND TOPICAL NSAR'S. TREATMENT WAS SUCCESSFUL AND THE CELLS +++ REACTION HAD CLEARED FULLY WITHIN 5 DAYS. THE HEALTHCARE FACILITY HAS NOT REPORTED ANY INJURY TO THE PT. IT IS UNCLEAR FROM THE INFO PROVIDED IF THIS IS AN INFLAMMATORY REACTION OR AN EXTRA PROLIFERATION OF ENDOTHELIAL CELLS. THE TREATMENT PROVIDED TO THE PT SUGGESTS THAT THEY SUFFERED AN INFLAMMATORY RESPONSE POST CATARACT SURGERY. THE CAUSE OF THE INFLAMMATION COULD BE ATTRIBUTED TO MANY FACTORS INCLUDING: PT MEDICAL HISTORY (EG CO-EXISTING CO-MORBIDITIES SUCH AS HYPERTENSION), INSTRUMENT CLEANING (IMPROPER FLUSHING, ENZYMATIC CLEANERS AND ULTRASOUND BATHS) OR MEDICATIONS, SOLUTIONS, CONTAMINANTS FROM SURGICAL GLOVES OR OTHER PRODUCTS. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX ADVANCE ASPHERIC (B)(4) IOL BATCH 103E51324 SHOWED THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPEC CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF VIGILANCE DATA CONFIRMS THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE C-FLEX ADVANCE ASPHERIC (B)(4) IOL BATCH 103E51324.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THIS (B)(6) PARTNER OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX ADVANCE ASPHERIC (B)(4) IOL. THE EVENT DESCRIPTION PROVIDED STATES "CELLS --- REACTION OBSERVED 8 DAYS POST-OPERATIVELY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803689 C-FLEX ADVANCE ASPHERIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. ADV970 103E51324

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention TOPICAL NSAR'S| TOPICAL AND SUBTENONAL CORTICOIDS,