BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 3648078 · Received February 13, 2014

    Report

    Report Number
    9611165-2014-00008
    Event Type
    Injury
    Date Received
    February 13, 2014
    Date of Event
    June 19, 2006
    Report Date
    September 14, 2015
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS FIELD SAFETY CORRECTIVE ACTION (FSCA) BY RAYNER INTRAOCULAR LENSES LIMITED. IN TOTAL (B)(4) DEVICES AFFECTED BY THIS ISSUE WERE RELEASED TO MARKET. OF THESE (B)(4) DEVICES, (B)(4) WAS PLACED ON THE MARKET IN (B)(4), (B)(4) WERE PLACED ON THE MARKET IN (B)(4), (B)(4) WERE PLACED ON THE MARKET IN (B)(4), (B)(4) WERE PLACED ON THE MARKET IN THE (B)(4) AND (B)(4) WERE PLACED ON THE MARKET IN (B)(4). RAYNER MADE INITIAL CONTACT WITH ALL CUSTOMERS WHO HAD RECEIVED PRODUCT FROM THE AFFECTED BATCHES (012E32861, 012E32862 AND 012E32863) IN ORDER TO DETERMINE WHETHER THE AFFECTED PRODUCT HAD BEEN USED OR REMAINED IN THEIR STOCKS. RAYNER INTRAOCULAR LENSES LIMITED HAS ADVISED ALL HEALTHCARE PROFESSIONALS TO STOP USAGE OF THE IDENTIFIED MODELS. HEALTHCARE PROFESSIONALS AND DISTRIBUTORS HAVE BEEN ASKED TO QUARANTINE ANY PRODUCT FROM THE IDENTIFIED BATCHES THAT REMAIN IN THEIR STOCK AND TO DISTRIBUTE THE SUPPLIED FIELD SAFETY NOTICE (FSN) TO ANY OTHER PERSONS AFFECTED BY THE ACTION TAKEN. ALL CUSTOMERS WERE SENT A FSN RESPONSE FORM AND WERE ASKED TO COMPLETE AND RETURN THE FORM TO RAYNER INTRAOCULAR LENSES LIMITED. TO DATE, RAYNER INTRAOCULAR LENSES LIMITED HAS BEEN ADVISED THAT (B)(4) OF THE AFFECTED IOLS HAVE BEEN IMPLANTED AND THAT (B)(4) OF THE AFFECTED IOLS ARE BEING RETURNED. RAYNER INTRAOCULAR LENSES LIMITED IS CURRENTLY WAITING TO RECEIVE INFO ON THE DISPOSITION OF THE REMAINING IOLS FROM (B)(4) AND (B)(4). A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE AFFECTED M-FLEX 580F IOL BATCHES (JANUARY 2012) CONFIRMS THAT NO REPORTS, OTHER THAN THE INITIATING REPORT THAT THE LABEL OPTIC GRAPHIC INCORRECTLY IDENTIFIED THE OPTIC DIAMETER AS 6.25MM AS OPPOSED TO 5.25MM, RECEIVED FROM THE (B)(4) DISTRIBUTOR HAS BEEN RECEIVED AGAINST THE M-FLEX 58F IOL BATCH 012E32862. NO REPORTS, OF ANY NATURE, HAVE BEEN RECEIVED AGAINST THE M-FLEX 580F IOL BATCHES 012E32861 AND 012E32863. NO INFO HAS BEEN RECEIVED BY RAYNER INTRAOCULAR LENSES LIMITED TO INDICATE THAT ANY ADVERSE CONSEQUENCES HAVE OCCURRED FOLLOWING IMPLANTATION OF THE M-FLEX 580F IOLS SUBJECT TO THE (B)(4) FSCA.

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PATIENT UNDERWENT IMPLANTATION OF THE C-FLEX 570C IOL ON (B)(6) 2006. THE INFORMATION RECEIVED FROM THE HEALTHCARE FACILITY INDICATES THAT OPACIFICATION HAD BEEN PRESENT IN THE EYE SINCE (B)(6) 2012. THE C-FLEX 570C IOL WAS EXPLANTED FROM THE EYE ON (B)(6) 2015 AS THE HEALTHCARE PROFESSIONAL DETERMINED THAT OPACIFICATION HAD WORSENED AND THE PATIENT'S VISION WAS BEING NEGATIVELY IMPACTED. THE PATIENT IS REPORTED TO HAVE HAD DMEK (DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY) SURGERY AND HAS ALSO BEEN PRESCRIBED A WIDE RANGE OF TREATMENTS FOR OCULAR PROBLEMS. REPEAT SURGERY/TRAUMA IS KNOWN TO LEAD TO A BREAKDOWN OF THE BLOOD-AQUEOUS BARRIER. A BREAKDOWN OF THE BLOOD-AQUEOUS BARRIER MAY LEAD TO PRECIPITATION OF CALCIUM RESULTING IN THE LENS BECOMING CLOUDY IN APPEARANCE. THE C-FLEX 570C IOL WAS RECEIVED FOR ANALYSIS BY THE THIRD PARTY INDEPENDENT LABORATORY ON 21ST JULY 2015. ANALYSIS OF THE LENS IS IN PROGRESS. THE RESULTS OF THE DEVICE ANALYSIS WILL BE PROVIDED IN A FOLLOW-UP REPORT. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX 570C IOL BATCH 036E64441 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 (MARCH 2006) WAS CARRIED OUT 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 036E64441.

    Description of Event or Problem · 1

    IN (B)(6) 2014, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A CUSTOMER THAT M-FLEX 580F IOLS THEY HAD RECEIVED IN AN EARLIER SHIPMENT DOCUMENTED THE OVERALL DIAMETER OF THE DEVICE INCORRECTLY AS 6.25MM. THE CORRECT OVERALL DIAMETER OF THE DEVICE IS 5.75MM. AN INVESTIGATION WAS INSTIGATED UPON RECEIPT OF THIS NOTIFICATION AND FURTHER EVAL OF THE REPORTED LABELLING ERROR IDENTIFIED THAT ALL M-FLEX 580F +28.0D, +28.5D AND +29.0D ADD +3.0D DEVICE BATCHES WERE AFFECTED BY THIS ISSUE. AS A RESULT OF THE FINDINGS OF OUR INVESTIGATION, A PRECAUTIONARY VOLUNTARY RECALL WAS INITIATED IN (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2015, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX 570C IOL. THE EVENT DESCRIPTION PROVIDED TO (B)(6) BY THE REPORTING HEALTHCARE PROFESIONAL STATES THAT NON-REMOVABLE DEPOSITS ARE PRESENT ON THE PUPIL AREA OF THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95668 C-FLEX C-FLEX (HQL - INTRAOCULAR LENS) HQL RAYNER INTRAOCULAR LENSES LIMITED 570C 036E64441

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention