BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21951000 · Received May 2, 2025

    Report

    Report Number
    3012236936-2025-000124
    Event Type
    Injury
    Date Received
    May 2, 2025
    Report Date
    May 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4. A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: ADDITIONAL DEVICE INFORMATION: MODEL NUMBER: UNKNOWN SECTION D4: ADDITIONAL DEVICE INFORMATION: CATALOG NUMBER: UNKNOWN SECTION D4: ADDITIONAL DEVICE INFORMATION: SERIAL NUMBER: UNKNOWN SECTION D4: ADDITIONAL DEVICE INFORMATION: EXPIRATION DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED SECTION E1: REPORTER: MIDDLE NAME: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: ADDRESS - LINE 2: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: STATE, PROVINCE, OR TERRITORY: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE ARTICLE TITLED "ANALYSIS OF INTRAOCULAR LENS TILT AND DECENTRATION AFTER CATARACT SURGERY IN EYES WITH HIGH MYOPIA USING THE ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY" THAT A RETROSPECTIVE STUDY WAS DONE TO INVESTIGATE THE DEGREE OF INTRAOCULAR LENS (IOL) TILT AND DECENTRATION AFTER CATARACT SURGERY IN EYES WITH VARYING DEGREES OF MYOPIA USING THE ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY (AS-OCT). A TOTAL OF 76 PATIENTS (N=76 EYES) WERE ANALYZED AND DIVIDED INTO THREE GROUPS: MILD MYOPIA (EMMETROPIA TO -1.5 DIOPTER [D], GROUP 1, N=28 EYES), MODERATE MYOPIA (-1.5 D TO -6.0 D, GROUP 2, N= 32 EYES), AND HIGH MYOPIA (OVER -6.0 D, GROUP 3, N=16 EYES). THE CATALYST FSL PLATFORM (JOHNSON & JOHNSON VISION CARE, INC) WAS USED, AND PHACOEMULSIFICATION WAS PERFORMED USING SIGNATURE PRO (JOHNSON & JOHNSON VISION CARE, INC). HYDROPHOBIC 1-PIECE IOL (EYHANCE NON-TORIC, JOHNSON & JOHNSON) WAS IMPLANTED WITH THE LENS CENTER ALIGNED WITH THE VISUAL AXIS.AT 1-MONTH POSTOPERATIVE: IOL DECENTRATION (MM): GROUP 1= 0.23 ± 0.15 (0.55); GROUP 2= 0.32 ± 0.18 (0.95); GROUP 3= 0.44 ± 0.24 (0.78) IOL TILT (°): GROUP 1= 4.83 ± 1.41 (6.70); GROUP 2= 4.22 ± 1.33 (6.40); GROUP 3= 4.53 ± 2.34 (8.00) SPHERICAL EQUIVALENT (SE; DIOPTER): GROUP 3: -1.01 ± 1.40 (5.13)THERE WERE NO FURTHER INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072248 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other