BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3634574 · Received January 31, 2014

    Report

    Report Number
    3003563511-2014-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Report Date
    December 19, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LTD. REPORTS THE FOLLOWING INVESTIGATION FINDINGS; OUR REVIEW OF PRODUCTION RECORDS FOR THE T-FLEX ASPHERIC 623T IOL BATCH 021E19589 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. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE T-FLEX ASPHERIC 623T IOL ((B)(6) 2011) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE T-FLEX ASPHERIC 623T IOL BATCH 021E19589.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD. RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A T-FLEX ASPHERIC 623T INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE LENS GOT "JAMMED" INSIDE THE INJECTOR. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LTD'S MDR 9611165-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68580 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 623T 021E19589

    Patients

    Seq Age Sex Outcome Treatment
    1