BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21939103 · Received April 30, 2025

    Report

    Report Number
    3012236936-2025-000122
    Event Type
    Injury
    Date Received
    April 30, 2025
    Report Date
    April 30, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE/DATE OF BIRTH (MONTHS): AGES ARE 65.6 ± 8.8. SECTION A3: SEX/GENDER: (MALE: FEMALE): 20:24. SECTION A4 & A5: INFORMATION UNKNOWN, NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 18 JANUARY 2024. SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. SECTION H3- THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL LOT/SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: CITATION: DA RAN KIM, YOUNG CHAE YOON, WOONG-JOO WHANG, HO SIK HWANG AND KYUNG-SUN NA, OCULAR PARAMETERS ASSOCIATED WITH VISUAL PERFORMANCE OF ENHANCED MONOFOCAL INTRAOCULAR LENS, (2024), BMC OPHTHALMOLOGY; 24 : 74. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: OCULAR PARAMETERS ASSOCIATED WITH VISUAL PERFORMANCE OF ENHANCED MONOFOCAL INTRAOCULAR LENS. A RETROSPECTIVE STUDY WAS DONE TO FIND OUT WHICH OCULAR PARAMETERS AFFECT VISION PERFORMANCE AND PHOTIC PHENOMENON OF TECNIS EYHANCE ICB00 OR TECNIS EYHANCE TORIC DIU AT DIFFERENT DISTANCES. A TOTAL OF 58 EYES OF 43 PATIENTS UNDERWENT CATARACT SURGERY AND WERE IMPLANTED WITH EITHER THE TECNIS EYHANCE ICB00 (N=37 EYES OF 28 PATIENTS) OR TECNIS EYHANCE TORIC DIU (N=21 EYES OF 16 PATIENTS) IOLS. AT 1-MONTH POST-OP, IT WAS REPORTED THAT THE POSTOPERATIVE AVERAGE VALUE OF THE INTRAOCULER LENS (IOL) DECENTRATION AMOUNT WAS 0.25 ± 0.17 MM (RANGE 0.04, 0.63 MM, MEDIAN 0.22 MM). THE SPHERICAL ABERRATION (MICROM), VERTICAL COMA (ROOT MEAN SQUARE, MICROM), AND HORIZONTAL COMA (ROOT MEAN SQUARE, MICROM) VALUES WERE REPORTED AS FOLLOWS: SPHERICAL ABERRATION (MICROM): NEAR: -0.517. INTERMEDIATE: -0.239. DISTANCE: 0.194. VERTICAL COMA (ROOT MEAN SQUARE, MICROM): NEAR: 0.031. INTERMEDIATE: -0.115. DISTANCE: 0.156. HORIZONTAL COMA (ROOT MEAN SQUARE, MICROM): NEAR: -0.146. INTERMEDIATE: -0.194. DISTANCE: 0.151. ADDITIONALLY, IT WAS REPORTED THAT DEEPER ANTERIOR CHAMBER DEPTH (ACD) WAS ASSOCIATED WITH POORER TOTAL QUALITY OF VISION (QOV), PARTICULARLY IN GLARE, HALO, BLUR, AND FLUCTUATION PERCEPTION. (COUNTS / AVERAGES / PERCENTAGES OF ADVERSE EVENTS WERE NOT REPORTED) THERE WERE NO CLEAR DISTINCTION ON WHICH VALUES WERE ATTRIBUTED TO WHICH DEVICE. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356609 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ICB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown