BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3102298 · Received April 30, 2013

    Report

    Report Number
    9611165-2013-00030
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 24, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. THE HEALTHCARE PROFESSIONAL EXPLANTED THE T-FLEX ASPHERIC 623T AND IMPLANTED A BACK-UP LENS WITHOUT FURTHER COMPLICATION IN THE ORIGINAL PLANNED SURGERY SESSION. THE HEALTHCARE FACILITY HAS CONFIRMED THAT NO FURTHER REMEDIAL ACTION IS REQUIRED AND THAT THE PT WAS NOT INJURED AS A RESULT OF THIS EVENT. OUR REVIEW OF PRODUCTION RECORDS FOR THE T-FLEX ASHERIC 623T IOL BATCH 013E44501 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 CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MFR OF THE T-FLEX ASHERIC 623T IOL (JANUARY 2013) 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 013E44501. THE T-FLEX ASPHERIC 623T IOL IS NOT AVAILABLE IN THE USA; HOWEVER, DOES FEATURE THE SAME HAPTICS AS THE C-FLEX 570C AND C-FLEX ASPHERIC 970C IOLS WHICH ARE AVAILABLE IN THE USA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD RECEIVED NOTIFICATION FROM (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A T-FLEX ASPHERIC 623T IOL. THE EVENT DESCRIPTION PROVIDED BY THE REPORTER STATES "HAPTIC WAS BROKEN (SMALL PIECE) WHEN INJECTED IN THE EYE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187825 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 623T 013E44501

    Patients

    Seq Age Sex Outcome Treatment
    1