BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM

    MDR report key: 11633798 · Received April 8, 2021

    Report

    Report Number
    2648035-2021-07529
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P 9 80040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: UNKNOWN/ NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. PHONE: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION; 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON SAW A SLIGHT CRACK IN THE INTRAOCULAR LENS (IOL) DURING IMPLANTATION. DESPITE THIS, THE RESULTS HAVE BEEN EXCELLENT. NO PATIENT INJURY WAS REPORTED. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536115 TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM TECNIS SIMPLICITY TECNIS EYHANCE HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1