BEUDAMED
    FDA Adverse Event Other Summary report: N

    M-FLEX

    MDR report key: 3648153 · Received February 13, 2014

    Report

    Report Number
    9611165-2014-00023
    Event Type
    Other
    Date Received
    February 13, 2014
    Report Date
    January 16, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    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. (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). 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.

    Description of Event or Problem · 1

    IN (B)(4) 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)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95814 M-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 580F 012E32862

    Patients

    Seq Age Sex Outcome Treatment
    1