BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23885689 · Received December 23, 2025

    Report

    Report Number
    3012236936-2025-000343
    Event Type
    Injury
    Date Received
    December 23, 2025
    Report Date
    December 24, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474765269
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: FEMALE SECTION B-3 DATE OF EVENT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. THE BEST DATE ESTIMATION IS MAY 2025. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION G1-2 MANUFACTURER TELEPHONE NUMBER: (B)(6), (ERROR MESSAGE REGARDING FORMAT) DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED; IT REMAINS IMPLANTED. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED; THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER (PO) NUMBER. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE DXW300 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DURING A FOLLOW-UP VISIT, A FILM WAS OBSERVED BEHIND BOTH LENSES, WHICH IS A KNOWN OCCURRENCE IN APPROXIMATELY 1 IN 5 PATIENTS. THE PATIENT WILL REQUIRE A LASER PROCEDURE TO ADDRESS THE ACCUMULATIONS. THE LENSES WERE NOTED TO BE IN GOOD CONDITION. THE PATIENT LATER REPORTED EXPERIENCING COLOR DISTORTION AND BLURRY VISION IN BOTH EYES STARTING IN (B)(6) 2025, THOUGH THESE ISSUES WERE NOT DEBILITATING. AN YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE WAS PERFORMED ON (B)(6) 2025. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. PATIENT PROGNOSIS POST LASER PROCEDURE WAS REPORTED AS FULL RECOVERY WITH CLEAR VISION. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMANS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829438 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DXW300 05050474765269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention