BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-FLEX

    MDR report key: 3698329 · Received March 11, 2014

    Report

    Report Number
    3003563511-2014-00015
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Report Date
    January 16, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED REPORTS THE FOLLOWING INVESTIGATION FINDINGS; 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 580F IOL BATCH 012E32862. NO REPORTS, OF ANY NATURE, HAVE BEEN RECEIVED AGAINST THE M- FLEX 580F IOL BATCHES 012E 32861 AND 012E32863. NO INFORMATION 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 580F-14 (B)(4).

    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 EVALUATION OF THE REPORTED LABELING 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 RAYNER INTRAOCULAR LENSES LIMITED'S INVESTIGATION, A PRECAUTIONARY VOLUNTARY RECALL WAS INITIATED IN (B)(6). FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146291 M-FLEX HQL RAYNER INTRAOCULAR LENSES LTD 580F 012E32862

    Patients

    Seq Age Sex Outcome Treatment
    1