BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21937206 · Received April 30, 2025

    Report

    Report Number
    3012236936-2025-000116
    Event Type
    Injury
    Date Received
    April 30, 2025
    Report Date
    April 30, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-2 PATIENT AGE/DATE OF BIRTH: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-3A PATIENT SEX: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-3B PATIENT GENDER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-5 PATIENT ETHNICITY: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-6 PATIENT RACE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION B-3 DATE OF EVENT: ARTICLE ACCEPTANCE DATE: 05-APR 2024. SECTION D-4 CATALOG NUMBER: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 DEVICE SERIAL NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-4 DEVICE EXPIRATION DATE: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 UDI NUMBER: THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THERE IS NO INDICATION THE IOL WAS EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: DEVICE SERIAL NUMBER IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. SECTION H-4 DEVICE MANUFACTURE DATE: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 2138 DIPLOPIA, UNEXPECTED POSTOP REFRACTION, AND VISION LOSS. CITATION: DELL SJ, HANNAN SJ, VENTER JA, TEENAN D, HANNAN NC, RAJU D, BERRY CW, KISS HJ, SCHALLHORN JM. COMPARATIVE ANALYSIS OF CLINICAL AND PATIENT-REPORTED OUTCOMES OF A NEW ENHANCED MONOFOCAL IOL AND A CONVENTIONAL MONOFOCAL IOL. CLIN OPHTHALMOL. 2024 MAY 1;18:1157-1169. DOI: 10.2147/OPTH.S456332. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: COMPARATIVE ANALYSIS OF CLINICAL AND PATIENT-REPORTED OUTCOMES OF A NEW ENHANCED MONOFOCAL IOL AND A CONVENTIONAL MONOFOCAL IOL. A RETROSPECTIVE STUDY WAS DONE TO COMPARE THE OUTCOMES OF THE TECNIS EYHANCE ICB00 IOL, DESIGNED TO ENHANCE INTERMEDIATE VISION, TO A CONVENTIONAL TECNIS MONOFOCAL ZCB00 IOL. A TOTAL OF 766 PATIENTS (N=1532 EYES) THAT WERE EQUALLY DIVIDED INTO 383 PATIENTS IN EACH GROUP. THEY ALL UNDERWENT LENS REPLACEMENT SURGERY IN THE PRESENCE OR ABSENCE OF A CATARACT, COMPARING TWO TYPES OF IMPLANTED IOLS: A MONOFOCAL IOL WITH AN ENHANCED DEPTH OF FOCUS, TECNIS EYHANCE ICB00 (GROUP 1 = 766 EYES), TO A CONVENTIONAL ASPHERIC MONOFOCAL IOL, TECNIS ZCB00 (GROUP 2 = 766 EYES) (BOTH IOLS MANUFACTURED BY JOHNSON & JOHNSON VISION, INC, IRVINE, CA). DIAGNOSTIC SCANS ALSO INCLUDED WAVEFRONT ABERRATION MEASUREMENT AND SURGERIES WERE PERFORMED EITHER BY A STANDARD PHACOEMULSIFICATION TECHNIQUE, OR WITH THE ASSISTANCE OF A FEMTOSECOND LASER. EVENTS INCLUDED: LOSS OF 2 OR MORE LINES: (GROUP 1:1.6%; GROUP 2: 1.8%), LOSS OF 1 LINE: (GROUP 1:19.3%; GROUP 2: 12.0%), MYOPIA OF -1.0 D OR LESS IN THE DOMINANT EYE: (GROUP 1: 6.0% OR 23 OUT OF 383 EYES; GROUP 2: 16.4% OR 63 OUT OF 383 EYES). PATIENTS HAVING SIGNIFICANT DIFFICULTY WITH ANY OF THE PRESENTED SIDE EFFECTS RANGED BETWEEN 0.8% AND 1.8% IN GROUP 1 AND BETWEEN 0.5% AND 1.6% IN GROUP 2. GLARE (GROUP1: 1.61 ± 1.15; GROUP 2: 1.67 ± 1.17), HALO (GROUP1: 1.42 ± 1.06; GROUP 2: 1.41 ± 0.94), STARBURST (GROUP1: 1.42 ± 0.98; GROUP 2: 1.54 ± 1.13), GHOSTING/DOUBLE VISION (GROUP1: 1.24 ± 0.78; GROUP 2: 1.31 ± 0.89). OTHER J&J DEVICES WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. THERE WERE NO FURTHER INTERVENTIONS REPORTED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181334 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other