BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS EYHANCE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM

    MDR report key: 21973450 · Received May 6, 2025

    Report

    Report Number
    3012236936-2025-000114
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Report Date
    May 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), . SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SECTION H6 - DEVICE CODE(S): 1254 - DIFFICULT TO FOLD, UNFOLD OR COLLAPSE HAS BEEN REMOVED UPON FURTHER REVIEW OF THE FILE, IT WAS DETERMINED THAT THE REPORTED EVENT DOES NOT MEET THE CRITERIA FOR LOCAL REPORTABILITY SINCE NO INTERVENTION OCCURRED. THEREFORE, THE EVENT IS NO LONGER CONSIDERED REPORTABLE AND NO FURTHER REPORTS WILL BE SUBMITTED UNDER MFR REPORT NUMBER 3012236936 - 2025 - 0001145. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AS A GENERAL COMPLAINT THAT THERE HAVE BEEN ISSUES WITH STICKY HAPTICS AND SLOWLY UNFOLDING INTRAOCULAR LENSES (IOLS), WHICH WERE MENTIONED DURING A SALES VISIT. NO FURTHER DETAIL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513427 TECNIS EYHANCE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown