BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX ADVANCE ASPHERIC

    MDR report key: 4281266 · Received November 13, 2014

    Report

    Report Number
    9611165-2014-00079
    Event Type
    Injury
    Date Received
    November 13, 2014
    Report Date
    November 11, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER. THE INFO RECEIVED FROM RAYNER'S (B)(4) PARTNER STATES THAT THE HEALTHCARE FACILITY INITIALLY SUSPECTED THAT THE PT WAS SUFFERING FROM ENDOPHTHALMITIS. FURTHER INVESTIGATION OF THE EVENT BY THE HEALTHCARE FACILITY DETERMINED THAT FIBRIN REACTION HAD DEVELOPED POST-OPERATIVELY. THE HEALTHCARE FACILITY HAS CONFIRMED THAT THEY HAVE SUCCESSFULLY TREATED AND RESOLVED THE OBSERVED FIBRIN REACTION. THE VA OF THE PT POST TREATMENT IS 1.0. THE PT IS REPORTED TO BE "IN WELL CONDITION AGAIN." FIBRIN REACTION IS LISTED AS A COMPLICATION RELATED TO IOL SURGERY IN THE C-FLEX ADVANCE ASPHERIC IFU. RAYNER IS LIAISING WITH ITS (B)(4) PARTNER TO OBTAIN ADDITIONAL INFO ON THE REPORT OF FIBRIN REACTION IN ORDER TO DETERMINE THE CAUSE OF OR THE FACTORS CONTRIBUTING TO THE INCIDENT. OUR REVIEW OF PRODUCT RECORDS FOR THE C-FLEX ADVANCE ASPHERIC ADV970 IOL BATCH (B)(4) SHOWED THAT ALL MFG AND QUAL CHEFKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE C-FLEX ADVANCE ASPHERIC ADV970 IOL BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(4) PARTNER OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX ADVANCE ASPHERIC ADV970 IOL. THE EVENT DESCRIPTION PROVIDED STATES THAT FIBRIN REACTION WAS OBSERVED IN THE POST-OPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732201 C-FLEX ADVANCE ASPHERIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. ADV970 093E51355

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention VANCOMYCIN| GENTAX GEL| BETNESOL GEL (CORTISONE)| FLOXAL GEL| CEFTAZIDIME