BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3000074 · Received March 8, 2013

    Report

    Report Number
    9611165-2013-00009
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    January 28, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    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 LIMITED. DESPITE VARIOUS ATTEMPTS BY RAYNER PERSONNEL TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED EVENT, NO FURTHER INFORMATION HAS BEEN FORTHCOMING FROM THE HEALTHCARE FACILITY. THE HEALTHCARE FACILITY HAS NOT REPORTED ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE INCIDENT AS REPORTED; HOWEVER, COULD NOT ASCERTAIN THE ROOT CAUSE OF HAPTIC BREAKAGE. OUR REVIEW OF PRODUCTION RECORDS FOR THE T-FLEX ASPHERIC 623T BATCH 080E14334 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED THE SUCCESSFUL RESULTS. ALL LENSES RELATED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA SINCE THE MONTH OF MANUFACTURE OF THE T-FLEX ASPHERIC 623T IOL (AUGUST 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 623T BATCH 0880E14334. THE T-FLEX ASPHERIC 623T IOL IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA; HOWEVER, DOES FEATURE THE SAME HAPTICS AS THE C-FLEX 570C AND C-FLEX ASPHERIC 970C IOLS WHICH ARE AVAILABLE IN THE UNITED SATES OF AMERICA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) HOSPITAL OF AN EVENT THAT OCCURRED DURING USE OF A T-FLEX ASPHERIC 623T INTRAOCULAR LENS. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS HAPTIC "SHEARED" OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98918 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 623T 080E14334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention