BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 2504953 · Received March 23, 2012

    Report

    Report Number
    9611165-2012-00013
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 16, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAS BEEN ALLOCATED THE REFERENCE (B)(4) BY RAYNER INTRAOCULAR LENSES LIMITED. THE PHYSICIAN INFORMED RAYNER INTRAOCULAR LENSES LIMITED THAT HE WAS ABLE TO IMPLANT A BACK-UP T-FLEX ASPHERIC 623T +20.5/+4.5D INTRAOCULAR LENS IN THE SAME SURGERY SESSION WITH NO ADVERSE EFFECT TO THE PT. A REVIEW OF PRODUCTION RECORDS FOR THIS BATCH CONFIRMS THAT ALL MANUFACTURING AND QUALITY CHECKS WERE SATISFACTORY AND THAT THE LENSES RELEASED FROM THE T-FLEX ASPHERIC 623T BATCH 070E12990 WERE ALL WITHIN SPECIFICATION. COMPLAINTS SINCE 07/2010, THE MONTH OF MANUFACTURE, WERE REVIEWED AND WE CAN CONFIRM THAT NO COMPLAINTS OF ANY TYPE HAVE BEEN RECEIVED AGAINST THE T-FLEX ASPHERIC 623T BATCH 070E12990. THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA. (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED WERE NOTIFIED OF AN EVENT THAT OCCURRED WHILST USING THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS BY THE (B)(6) HOSPITAL. THE HEALTHCARE FACILITY HAS INFORMED RAYNER INTRAOCULAR LENSES LIMITED THAT UPON INSERTION OF THE T-FLEX ASPHERIC 623T INTO THE EYE THAT THE HAPTIC "SNAPPED OFF". THE T-FLEX ASPHERIC 623T WAS EXPLANTED BY THE PHYSICIAN AND A BACK-UP LENS OF THE SAME MODEL AND POWER WAS IMPLANTED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 623T 070E12990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention