BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20340188 · Received September 30, 2024

    Report

    Report Number
    3012236936-2024-000258
    Event Type
    Injury
    Date Received
    September 30, 2024
    Report Date
    September 30, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 68.45±6.38 SECTION A3: 62% OF THE PATIENTS WERE FEMALE SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JANUARY 31, 2023. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN JANUARY 2005 AND DECEMBER 2007. SECTION D4 - SERIAL NUMBER: UNKNOWN/ NOT PROVIDED SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3: THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBERS WERE 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 NUMBERS WERE NOT PROVIDED. SECTION H6 - HEALTH EFFECT - CLINICAL CODE: 4581 NO CODE AVAILABLE (DEVICE DISLOCATED) CITATION: ROSA GIGLIO ARTICLE: BILATERAL IMPLANTATION OF MULTIFOCAL INTRAOCULAR LENSES: 10-YEAR FOLLOW-UP . KLIN MONATSBL AUGENHEILKD 2023; 240: 426¿434 DOI 10.1055/A-2031-2556 ISSN 0023-2165 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: BILATERAL IMPLANTATION OF MULTIFOCAL INTRAOCULAR LENSES: 10-YEAR FOLLOW-UP A RETROSPECTIVE COMPARATIVE STUDY WAS DONE TO EVALUATE AND COMPARE THE LONG-TERM RESULTS AFTER BILATERAL IMPLANTATION OF DIFFERENT MULTIFOCAL INTRAOCULAR LENSES (MIOLS). A TOTAL OF 42 PATIENTS UNDERWENT CATARACT SURGERY WITH BILATERAL MIOL IMPLANTATION. THE PATIENTS WERE DIVIDED INTO 5 GROUPS: GROUP 1 RECEIVED A REFRACTIVE REZOOM NGX1 INTRAOCULAR LENS (IOL) (N=5 PATIENTS; AMO), GROUP 2 A DIFFRACTIVE ACRYSOF RESTOR SA60D3 IOL (N=6 PATIENTS; ALCON), AND GROUP 3 A DIFFRACTIVE TECNIS ZM900 IOL (N=10 PATIENTS; AMO). GROUP 4 AND GROUP 5 WERE IMPLANTED USING THE MIX AND MATCH APPROACH WITH REFRACTIVE REZOOM-DIFFRACTIVE RESTOR IOL (N=10 PATIENTS) AND REFRACTIVE RE-ZOOM-DIFFRACTIVE TECNIS ZM900 IOL (N=11 PATIENTS), RESPECTIVELY. AT 10 YEARS POST-OP, IT WAS REPORTED THAT POSTERIOR CAPSULAR OPACIFICATION (PCO) OCCURRED IN 15 EYES IMPLANTED WITH REZOOM AND IN 4 EYES IMPLANTED WITH THE ZM900. ALL PATIENTS WITH PCO UNDERWENT NG:YAG (NEODYMIUM YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY. IN GROUP 3 (TECNIS ZM900), THERE WAS ONE CASE OF IOL DISLOCATION. SPECTACLE DEPENDENCE WAS REPORTED IN 70% OF PATIENTS IN GROUP 1 (REZOOM NGX1), 40% IN GROUP 3 (TECNIS ZM900), 30% IN GROUP 4 (REZOOM-DIFFRACTIVE RESTOR), AND 36.4% IN GROUP 5 (RE-ZOOM-DIFFRACTIVE TECNIS ZM900). NONE TO MINIMAL PHOTIC PHENOMENA (HALOS/GLARE) WERE REPORTED IN 60% OF PATIENTS IN GROUP 1, 77.8% IN GROUP 3, 55.6% IN GROUP 4, AND 70% IN GROUP 5. MODERATE PHOTIC PHENOMENA (HALOS/GLARE) WERE REPORTED IN 20% OF PATIENTS IN GROUP 1, 22.2% IN GROUP 3, 11.1% IN GROUP 4, AND 10% IN GROUP 5. SEVERE PHOTIC PHENOMENA (HALOS/GLARE) WERE REPORTED IN 20% OF PATIENTS IN GROUP 1, 33.3% IN GROUP 4, AND 20% IN GROUP 5." THIS REPORT IS FOR THE LENS TECNIS ZM900. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LENS REZOOM NGX1. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45477 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZM900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention