BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14183555 · Received April 22, 2022

    Report

    Report Number
    3012236936-2022-00957
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 23, 2022
    Report Date
    August 23, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT: UNKNOWN, IT WAS ASKED, BUT THE INFORMATION WAS NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE OPTIBLUE SIMPLICITY, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY TECNIS EYHANCE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. WEIGHT THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT WAS OBSERVED THAT SECTION "G2" SHOULD HAVE INCLUDED "COMPANY REPRESENTATIVE" WHICH INADVERTENTLY WAS NOT SELECTED IN THE INITIAL MDR REPORT. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION G2 - REPORT SOURCE ADDED: COMPANY REPRESENTATIVE. ADDITIONAL INFORMATION: THE CUSTOMER PROVIDED A VIDEO WHICH WAS EVALUATED BY BOTH A JOHNSON & JOHNSON MEDICAL SUBJECT MATTER EXPERT (SME), AND A PRINCIPAL ENGINEERING SME. BASED ON THE VIDEO EVALUATION, THE PARTICLE APPEARED SOFT IN NATURE AS IT WAS EASILY REMOVED FROM THE EYE WITH IRRIGATION ASPIRATION. THE SOURCE, ROOT-CAUSE, OR POTENTIAL CLINICAL IMPACT COULD NOT BE DETERMINED FROM A VIDEO ASSESSMENT. THE COMPLAINT ISSUE WAS CONSIDERED VERIFIED; HOWEVER, BASED ON THE INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GLUE-LIKE FOREIGN BODY WAS FOUND ON THE BACK SURFACE OF AN INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. THE PHYSICIAN DETERMINED THAT IT COULD NOT BE CORTEX BECAUSE PATIENT-DERIVED CORTEX HAD THOROUGHLY BEEN ABSORBED. THE FLOATING FOREIGN BODY WAS REMOVED WITH IRRIGATION/ASPIRATION (IA), AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INDICATED THAT THE MATERIAL SEEMED TO BE A KIND OF COATING AGENT. THERE WAS NO PATIENT INJURY REPORTED. THERE IS NO RETURNING PRODUCT BECAUSE THE LENS REMAINS IMPLANTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT HAS NO PROBLEM WITH THEIR HEALTH AND THERE IS NO INJURY POST OPERATION WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327288 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown