BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-FLEX T MULTIFOCAL TORIC

    MDR report key: 2062061 · Received March 16, 2011

    Report

    Report Number
    9611165-2011-00004
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 15, 2011
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT DISTRIBUTED WITHIN THE US; HOWEVER, SINCE THE LENS IS SIMILAR TO THE RAYNER 570C IOL, AVAILABLE IN THE USA, THIS EVENT IS BEING REPORTED. THE DAMAGE TO THE TRAILING HAPTIC LED TO THE INITIAL LENS BEING EXPLANTED, LEADING TO SUTURING TO SEAL THE WOUND. REVIEW OF BATCH HISTORY RECORDS INDICATES ROUTINE MANUFACTURING AND STERILIZATION OF ALL LENSES IN THE BATCH. (B)(4).

    Description of Event or Problem · 1

    THE LENS STUCK TO THE INNER PACKAGING JUST UNDER THE EXTERNAL PEEL. IT WAS NOT EASY TO REMOVE THE LENS. THE SCRUB NURSE MANAGED TO FREE THE LENS. THE TRAILING HAPTIC WAS DAMAGED FOLLOWING INSERTION OF THE LENS INTO THE EYE. NO UNUSUAL RESISTANCE OF THE PLUNGER WAS NOTICED BY THE EXPERIENCED SCRUB NURSE OR DOCTOR. THE LENS WAS EXPLANTED BY THE SURGEON. A BACK-UP LENS WAS IMPLANTED. THE PT IS SEEING WELL POST-OPERATIVELY DESPITE HAVING SUTURES INSERTED TO SEAL THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-FLEX T MULTIFOCAL TORIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 588F 100E1636002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention