BEUDAMED
    FDA Adverse Event Other Summary report: N

    M-FLEX

    MDR report key: 3993513 · Received July 22, 2014

    Report

    Report Number
    9611165-2014-00063
    Event Type
    Other
    Date Received
    July 22, 2014
    Report Date
    July 18, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LTD. HAS ALLOCATED THE REFERENCE (B)(4) TO THIS CASE. INFORMATION OBTAINED FROM THE HEALTHCARE PROFESSIONAL STATES THAT ROUTINE PRE-OP EVALUATION AND BIOMETRY USING TOPCON MANUAL KERATOMETER AND SONOMED BAROMETER WERE CARRIED OUT. THE SURGEON USED A CLEAR CORNEAL INCISION OF 2.75MM WHICH WAS PLACED AT THE STEEPER MERIDIAN. NO COMPLICATIONS DURING THE INITIAL IMPLANT PROCEDURE HAVE BEEN REPORTED. POST-OPERATIVE ASSESSMENT WAS PERFORMED ON DAY ONE, WEEK ONE, ONE MONTH AND SIX MONTHS THEREON. THE SURGEON DETERMINED THAT YAG CAPSULOTOMY WAS REQUIRED SIX MONTHS POST-OPERATIVELY. THE REASON FOR YAG HAS NOT BEEN SPECIFIED. RAYNER IS LIAISING WITH THE HEALTHCARE FACILITY TO DETERMINE WHY YAG WAS PERFORMED. THE HEALTHCARE FACILITY REPORTS THAT 2 WEEKS POST YAG CAPSULOTOMY THE PATIENT DEVELOPED AN EPITHELIAL DEFECT. THE EPITHELIAL DEFECT LED TO CORNEAL NEBULA "TOUCHING THE VISUAL AXIS". THE PATIENT IS REPORTED TO BE "COMFORTABLE WITH BOTH EYES OPEN".

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD. RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A M-FLEX 630F INTRAOCULAR LENS (IOL). THE PATIENT WAS REQUIRED TO UNDERGO YAG CAPSULOTOMY FOR AN UNSPECIFIED REASON SIX MONTHS AFTER IOL IMPLANTATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428484 M-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 630F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention