BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18938124 · Received March 19, 2024

    Report

    Report Number
    3012236936-2024-00642
    Event Type
    Injury
    Date Received
    March 19, 2024
    Report Date
    March 19, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 62.1 ±11.8 SECTION A3: 22 FEMALE AND 17 MALE PATIENTS SECTION B3: DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS 25 NOVEMBER 2021. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN DECEMBER 2017 AND JUNE 2020. SECTION D6B: EXPLANT DATE: N/A, LENS REMAINS IMPLANTED. SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS TORIC I OPTIBLUE 1-PIECE IOL, MODEL ZCV THAT HAS A SIMILAR DEVICE, TECNIS TORIC 1-PIECE IOL MODEL ZCT SERIES WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE 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: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: SAKAI, D., TAKAGI, S., HIRAMI, Y., NAKAMURA, M., & KURIMOTO, Y. (2023). USE OF ELLIPSOID ZONE WIDTH FOR PREDICTING VISUAL PROGNOSIS AFTER CATARACT SURGERY IN PATIENTS WITH RETINITIS PIGMENTOSA. EYE (LONDON, ENGLAND), 37(1), 42¿47. HTTPS://DOI.ORG/10.1038/S41433-021-01878-3 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 A LITERATURE REVIEW: ARTICLE: USE OF ELLIPSOID ZONE WIDTH FOR PREDICTING VISUAL PROGNOSIS AFTER CATARACT SURGERY IN PATIENTS WITH RETINITIS PIGMENTOSA A RETROSPECTIVE STUDY WAS DONE TO PREDICT THE VISUAL PROGNOSIS OF CATARACT SURGERY IN PATIENTS WITH RETINITIS PIGMENTOSA BY MEASURING ELLIPSOID ZONE (EZ) WIDTH USING SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY (SD-OCT). THERE WERE 64 PATIENTS (N=103 EYES) WHO HAD UNCOMPLICATED CATARACT SURGERY AND WERE DIAGNOSED WITH RETINITIS PIGMENTOSA (RP). THERE WERE 43 EYES WHICH WERE EXCLUDED AND IF BOTH EYES OF ONE PATIENT WERE ELIGIBLE, ONLY ONE EYE WAS RANDOMLY SELECTED (N=22 EYES); LEAVING A TOTAL OF 38 PATIENTS (N=38 EYES) THAT WERE INCLUDED. STANDARD PHACOEMULSIFICATION WAS PERFORMED IN ALL CASES. INTRAOCULAR LENS (IOL) IMPLANTATION WAS PERFORMED IN 37 EYES. AMONG THEM, 27 EYES (73.0%) RECEIVED NX-70 (SANTEN, OSAKA, JAPAN). THE REMAINING EYES RECEIVED OTHER INTRAOCULAR LENSES, INCLUDING DCB00V, PCB00V, AND ZCV (AMO, SANTA ANA, CA, USA); XY-1 (HOYA SURGICAL OPTICS, TOKYO, JAPAN); SN6A AND CNA0T0 (ALCON LABORATORIES, FORT WORTH, TX, USA); AND PN6A (KOWA, TOKYO, JAPAN). ONE EYE WAS INTENTIONALLY LEFT APHAKIC BECAUSE OF HIGH MYOPIA. SD-OCT IMAGES WERE ACQUIRED USING SPECTRALIS (HEIDELBERG ENGINEERING, HEIDELBERG, GERMANY). EZ WIDTHS IN EACH EYE WERE MEASURED USING PREOPERATIVE OCT IMAGES. POSTOPERATIVE COMPLICATIONS WERE: DID NOT ACHIEVE A PREFERABLE VISUAL PROGNOSIS (>0.3 LOGMAR) (N=13 EYES) POSTERIOR CAPSULAR OPACIFICATION IN 10 EYES (26%), AND NEODYMIUM: YAG LASER CAPSULOTOMY WAS PERFORMED IN ALL CASES. ANTERIOR CAPSULE CONTRACTION IN THREE EYES (7.9%), AND NEODYMIUM: YAG LASER CAPSULOTOMY WAS PERFORMED IN ONE CASE. CYSTOID MACULAR OEDEMA (N=1) ON SD-OCT, AND THIS EYE WAS TREATED WITH TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY DRUGS. IT WAS UNCLEAR, IF IT WAS A JNJ DEVICE, OR THE OTHER DEVICES USED, THAT CAUSED THE EVENTS IN THE STUDY. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT AND SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO JNJ DEVICES MENTIONED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755192 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS ZCV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention