BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX

    MDR report key: 2771733 · Received October 1, 2012

    Report

    Report Number
    9611165-2012-00056
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    June 20, 2012
    Report Date
    September 7, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS COMPLAINT BY RAYNER INTRAOCULAR LENSES LIMITED. DESPITE VARIOUS ATTEMPTS BY VIGILANCE PERSONNEL TO OBTAIN ADDITIONAL INFO ON THE REPORTED HAPTIC BREAKAGE, NO INFO HAS BEEN FORTHCOMING FROM THE HEALTHCARE FACILITY. WITHOUT THE ABILITY TO EXAMINE THE PRODUCT AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED. OUR EXISTING COMPLAINT DATA, FROM THE DATE OF MANUFACTURE OF THE C-FLEX 570C IOL (09/2010) WAS REVIEWED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER COMPLAINTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE C-FLEX 570C BATCH 090E15363. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX 570C BATCH 090E15363 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 LIMITS AND WERE WITHOUT DEFECTS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A C-FLEX 570C INTRAOCULAR LENS. THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY INDICATES THAT THE LENS HAPTIC BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 570C 090E15363

    Patients

    Seq Age Sex Outcome Treatment
    1