BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15230182 · Received August 15, 2022

    Report

    Report Number
    3012236936-2022-02143
    Event Type
    Injury
    Date Received
    August 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    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

    AGE/DATE OF BIRTH (MONTHS): AGES ARE 64.55 ± 6.73. SEX/GENDER: (MALE/ FEMALE): 19/18. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 28 JULY 2021. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, DEVICE REMAINS IMPLANTED. DEVICE EVALUATED BY MFR: 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. 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: A PROSPECTIVE CLINICAL STUDY WAS DONE TO EVALUATE THE CLINICAL OUTCOMES AFTER BILATERAL MIX-AND-MATCH CATARACT SURGERY USING EXTENDED DEPTH OF FOCUS (EDOF) AND DIFFRACTIVE MULTIFOCAL (DMF) INTRAOCULAR LENSES (IOLS). A TOTAL OF 74 EYES OF 37 PATIENTS WITH CATARACTS UNDERWENT TECNIS SYMFONY EDOF IOL (ZXR00) (JOHNSON AND JOHNSON VISION) IMPLANTATION IN THE DOMINANT EYE, AND TECNIS +3.25 DMF IOL (ZLB00) (JOHNSON AND JOHNSON VISION) IMPLANTATION IN THE NONDOMINANT EYE. INTRAOPERATIVELY, A RADIAL TEAR OCCURRED IN ONE EYE IMPLANTED WITH THE TECNIS ZLB00 IOL, A POSTERIOR CAPSULAR RENT DEVELOPED IN 2 EYES IMPLANTED WITH THE TECNIS ZXR00 IOL, AND AN ANTERIOR VITRECTOMY WAS PERFORMED IN THESE EYES BECAUSE OF VITREOUS LOSS. IT WAS REPORTED THAT ONLY 3 SUBJECTS REPORTED NEEDING GLASSES OCCASIONALLY FOR NEAR VISION AFTER SURGERY. A TOTAL OF 8 SUBJECTS REPORTED GLARE AND HALO SYMPTOM SCORES WORSE THAN 3 (AVERAGE SCORE: 2.6 ± 1.0) (RANGE: 1=ABSENCE OF SYMPTOMS; 5=VERY SEVERE SYMPTOMS). FURTHERMORE, THE PROPORTION OF PATIENTS THAT REPORTED SEVERE PHOTIC PHENOMENA WAS QUITE LOW (APPROXIMATELY 20%). THERE WERE NO FURTHER INDICATIONS IN THE ARTICLE OF ANY OTHER INTERVENTIONS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: JAE HYUCK LEE, HO SEOK CHUNG, SU YOUNG MOON, SO YOUNG PARK, HUN LEE, JAE YONG KIM, AND HUNGWON TCHAH, CLINICAL OUTCOMES AFTER MIX-AND-MATCH IMPLANTATION OF EXTENDED DEPTH OF FOCUS AND DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES, (2021), JOURNAL OF OPHTHALMOLOGY; ISSUE 8881794, & VOLUME 2021: PP 1-7 THIS REPORT IS FOR LENS MODEL ZXR00. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER MODEL MENTIONED IN THE ARTICLE, ZLB00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950271 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention