BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13974012 · Received April 1, 2022

    Report

    Report Number
    3012236936-2022-00823
    Event Type
    Injury
    Date Received
    April 1, 2022
    Report Date
    March 31, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, YEARS: 72.5 ± 9.4. GENDER: MALE/FEMALE: 33/37. PATIENT WEIGHT: INFORMATION UNKNOWN/NOT PROVIDED. ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. RACE: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: EXACT DATE IS NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 7/1/2021. CATALOG NUMBER: COMPLETE CATALOG NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: COMPLETE MODEL NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, THE INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: THE UDI NUMBER IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, THE INFORMATION WAS NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: UNFOLDER PLATINUM INJECTOR AND HEALON FROM JOHNSON & JOHNSON VISION CARE, INC. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CITATION: TAKAKU, R., NAKANO, S., IIDA, M., OSHIKA, T., INFLUENCE OF FROSTED HAPTICS ON ROTATIONAL STABILITY OF TORIC INTRAOCULAR LENSES. SCI REP 11, 15099 (2021). HTTPS://DOI.ORG/10.1038/S41598-021-94293-3 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 LITERATURE REVIEW. ARTICLE: INFLUENCE OF FROSTED HAPTICS ON ROTATIONAL STABILITY OF TORIC INTRAOCULAR LENSES A RETROSPECTIVE STUDY WAS DONE TO COMPARE TECNIS TORIC-I (CONVENTIONAL MODEL) AND TORIC-II (NEW MODEL) IOLS, IN TERMS OF UNFOLDING PROPERTY AND SURGICAL OUTCOMES. A TOTAL OF 131 EYES OF 99 PATIENTS WITH CATARACT UNDERWENT PHACOEMULSIFICATION AND TORIC IOL IMPLANTATION. TWO MODELS OF TECNIS TORIC IOLS WERE USED: TORIC IOL (TORIC-I IOL, ZCV) (N=70 EYES) AND TORIC II IOL (TORIC-II IOL, ZCW) (61 EYES) (JOHNSON & JOHNSON VISION CARE, INC.). DURING THE PROCEDURE, THE IOLS WERE SET IN THE INJECTOR CARTRIDGE (UNFOLDER PLATINUM INJECTOR, JOHNSON & JOHNSON VISION CARE, INC.) WITH AN OPHTHALMIC VISCOELASTIC DEVICE (SODIUM HYALURONATE 1.0%, HEALON, JOHNSON & JOHNSON VISION CARE, INC.). REPOSITIONING SURGERY TO CORRECT MAJOR AXIS MISALIGNMENT WAS PERFORMED IN 2 EYES IN THE TORIC-I IOL GROUP WITH A MISALIGNMENT OF 42 DEGREES AND 37 DEGREES, 14 DAYS AFTER THE PRIMARY CATARACT SURGERY. SURGICAL RESULTS AT 3 MONTHS POSTOPERATIVELY SHOWS THAT THE AMOUNT OF RESIDUAL MANIFEST ASTIGMATISM WAS SIGNIFICANTLY SMALLER IN THE TORIC-II IOL THAN IN THE TORIC-I IOL GROUPS (P = 0.018). THE EYES IMPLANTED WITH TORIC-II IOL PRESENTED SIGNIFICANTLY SMALLER AMOUNT OF AXIS MISALIGNMENT FROM THE INTENDED AXIS THAN THOSE RECEIVED TORIC-I IOL (P = 0.04). THE PERCENTAGE OF EYES WITH MISALIGNMENT OF > 10° WAS SIGNIFICANTLY SMALLER WITH TORIC-II IOLS THAN WITH TORIC-I IOLS (P = 0.0044). A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. WITHIN THE ARTICLE, THE FOLLOWING MODELS (150/225/300/375) WERE INDICATED, HOWEVER, THE EXACT MODEL OF THE TORIC LENS CANNOT BE CORRELATED TO THE REPORTED EVENT SINCE IT WAS NOT SPECIFIED IN THE THE ARTICLE. THIS REPORT IS FOR THE INTRAOCULAR LENS, MODEL ZCV -TORIC-I LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LISTED MODEL, ZCW -TORIC-II LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564026 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS UNK-ZCV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention