BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21713497 · Received March 27, 2025

    Report

    Report Number
    3012236936-2025-000082
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 27, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474763005
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: THE CUSTOMER REPORTED ¿FEMALE¿. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT WAS NOT ABLE TO HANDLE THE MULTIFOCALITY OF THE IOL. THE PATIENT WAS UNABLE TO SEE CLEARLY, NOT HAPPY WITH THEIR VISION. THE PATIENT STATED, ¿SOMETHING IS WRONG WITH MY VISION¿. THE EXPLANTED IOL WAS REPLACED WITH A BAUSCH AND LOMB LENS, MODEL 21.5 LI61A0. THE PATIENT WAS NOT INJURED AND THERE WAS NO MEDICAL INTERVENTION OR COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT WAS REPORTED AS DOING WELL SO FAR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416598 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DXW150 05050474763005

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention