BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 22057609 · Received May 20, 2025

    Report

    Report Number
    3012236936-2025-000146
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746404
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE; THEREFORE, NOT EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    FOLLOWING INSERTION THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED WHILE UNFOLDING IN THE EYE. THE IOL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO PATIENT INJURY HOWEVER, IT IS UNKNOWN IF ANY MEDICAL INTERVENTION OR SURGICAL INTERVENTION WAS REQUIRED DURING THE PROCEDURE. THE IOL WAS PREPPED FOR ABOUT FIVE (05) MINUTES PRIOR TO INSERTION AND IT IS UNSURE IF BALANCED SALT SOLUTION (BSS) OR OPHTHALMIC VISCOSURGICAL DEVICE - VISCOELASTIC (OVD) WAS USED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS SEEMED STABLE AND NORMAL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81472 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male