BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3072619 · Received April 19, 2013

    Report

    Report Number
    9611165-2013-00027
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. OUR REVIEW OF PRODUCTION RECORDS FOR THE T-FLEX ASPHERIC 573T IOL BATCH 110E17615 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 CRITERIA AND WERE WITHOUT DEFECTS. (B)(4). THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OR ANY TYPE, HAVE BEEN RECEIVED AGAINST THE T-FLEX ASPHERIC 573T IOL BATCH 110E17615. DESPITE VARIOUS ATTEMPTS MADE BY RAYNER PERSONNEL TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED EVENT, NO FURTHER DATA HAS BEEN FORTHCOMING FROM THE HEALTHCARE FACILITY. WITHOUT CLEAR EVENT DETAILS BEING PROVIDED A FAILURE MODE AND ROOT CAUSE ARE EXTREMELY DIFFICULT TO ASCERTAIN. THE T-FLEX ASPHERIC 573T IOL IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA; HOWEVER, DOES FEATURE THE SAME HAPTICS AS THE C-FLEX 570C AND C-FLEX ASPHERIC 970C WHICH ARE AVAILABLE IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE ALL CLEAR CLINIC (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A T-FLEX ASPHERIC 573T IOL. THE REPORT RECEIVED INDICATED THAT THE IOL WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169186 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 573T 110E17615

    Patients

    Seq Age Sex Outcome Treatment
    1