BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3050190 · Received April 4, 2013

    Report

    Report Number
    9611165-2013-00020
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    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 (B)(4). THE HEALTHCARE FACILITY REPORTED THAT THE T-FLEX ASPHERIC 573T WAS EXPLANTED. THE HEALTHCARE PROFESSIONAL IMPLANTED THE BACK UP LENS WITHOUT FURTHER COMPLICATION IN THE ORIGINAL PLANNED SURGERY SESSION. OUR DEVICE ANALYSIS CONCLUDED THAT "IT HAS NOT BEEN POSSIBLE TO CONFIRM CAUSE OF LENS DAMAGE. DAMAGE TO HAPTIC CONSISTENT WITH THE TIP BEING TRAPPED BETWEEN THE FLAPS DURING LOADING, AND THEN DAMAGED DURING INSERTION OF THE LENS BUT THIS WAS IMPOSSIBLE TO CONFIRM." OUR REVIEW OF PRODUCTION RECORDS FOR THE T-FLEX ASPHERIC 573T BATCH 030E99507 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 573T IOL (MARCH 2010) 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 573T IOL BATCH 030E99507.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A T-FLEX ASPHERIC 573T IOL. THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT THE LENS WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139189 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 573T 030E99507

    Patients

    Seq Age Sex Outcome Treatment
    1