BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 2634028 · Received June 26, 2012

    Report

    Report Number
    9611165-2012-00030
    Event Type
    Injury
    Date Received
    June 26, 2012
    Date of Event
    June 15, 2012
    Report Date
    June 15, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS COMPLAINT BY RAYNER INTRAOCULAR LENSES LTD. THE PHYSICIAN EXPLANTED THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS. THIS INCISION HAD TO BE ENLARGED TO AID EXPLANTATION AND CONSEQUENTLY, SUTURING WAS NECESSARY. WHEN THE ORDER FOR THE T-FLEX ASPHERIC 623T SUBJECT TO THIS REPORT WAS PLACED THE HOSP INSTRUCTED RAYNER NOT TO PROVIDE A BACK-UP T-FLEX ASPHERIC 623T INTRAOCULAR LENS OF THE SAME POWER THEREFORE, A SECONDARY SURGICAL PROCEDURE HAS BEEN SCHEDULED. OUR REVIEW OF PRODUCTION RECORDS OF THE T-FLEX ASPHERIC (B)(4) CONFIRMS THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED SUCCESSFULLY. ALL LENSES RELEASED FROM THIS BATCH WERE WITHIN TOLERANCE AND SPEC. COMPLAINTS SINCE APRIL 2012, THE MONTH OF MANUFACTURE, WERE REVIEWED AND WE CAN CONFIRM THAT NO COMPLAINTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE T-FLEX ASPHERIC (B)(4). THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA. HOWEVER, THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS HAPTICS ARE THE SAME AS THOSE ON THE C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES. THE C-FLEX 570C AND C-FLEX ASPHERIC 970C ARE AVAILABLE IN THE USA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE SPANISH DIST OF AN INCIDENT THAT OCCURRED DURING THE USE OF A T-FLEX ASPHERIC 623T INTRAOCULAR LENS. THE DESCRIPTION OF THE EVENT IS AS FOLLOWS "AFTER PREPARING THE IOL IN THE INJECTOR, AND INSERTING THE IOL INTO THE LENS BAG, I REALIZED THAT THE BACK HAPTIC WAS BROKEN IN THE POINT IT IS JOINED TO THE OPTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 623T 042E36601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention