BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 2890572 · Received November 26, 2012

    Report

    Report Number
    9611165-2012-00076
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 1, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. RAYNER INTRAOCULAR LENSES LTD HAVE BEEN ADVISED BY THE (B)(4) DISTRIBUTOR THAT THE PHYSICIAN EXPLANTED THE C - FLEX ASPHERIC 970C INTRAOCULAR LENS AND IMPLANTED A BACK-UP INTRAOCULAR LENS OF THE SAME MODEL AND POWER IN THE ORIGINAL PLANNED SURGERY SESSION WITHOUT ANY ADVERSE EVENT TO THE PT. THE CONDITION OF THE PT POST-OPERATIVELY HAS BEEN DESCRIBED AS "EXCELLENT" BY THE HEALTHCARE FACILITY. THE EVENT DESCRIPTION PROVIDED BY THE CANADIAN DISTRIBUTOR INDICATES THAT THE EVENT OCCURRED AS A RESULT OF USER ERROR, THEREFORE ADDITIONAL LENS LOADING TRAINING, SINCE THIS EVENT, HAS BEEN PROVIDED TO THE PHYSICIAN TO PREVENT THE RECURRENCE OF THIS ISSUE. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX ASPHERIC 970C BATCH 121E31751 SHOWED THAT ALL MFG 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. OUR EXISTING VIGILANCE DATA SINCE THE MONTH OF MANUFACTURE OF THE C-FLEX ASPHERIC 970C INTRAOCULAR LENS (DECEMBER 2011) WAS REVIEWED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVING AGAINST THE C-FLEX ASPHERIC 970C BATCH 121E31751.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING USE OF A C-FLEX ASPHERIC 970C INTRAOCULAR LENS. THE EVENT DESCRIPTION PROVIDED STATES "HAPTIC BROKE WHEN INJECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 970C 121E31751

    Patients

    Seq Age Sex Outcome Treatment
    1