BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11691747 · Received April 20, 2021

    Report

    Report Number
    2648035-2021-07554
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    September 24, 2020
    Report Date
    April 20, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: EXACT AGES WERE NOT PROVIDED, ONLY INFORMATION GIVEN IS PATIENTS ARE LESS THAN OR EQUAL TO (B)(6) YEARS OLD. SEX: PATIENT GROUP WAS REPORTED TO BE BOTH MALE AND FEMALE, HOWEVER, IT IS UNKNOWN WHICH GENDER RECEIVED WHICH LENS. WEIGHT AND ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN, (B)(6) 2020 IS PROVIDED AS IT IS THE PUBLISHED DATE OF THE ARTICLE. SERIAL #: INFORMATION UNKNOWN NOT PROVIDED EXPIRATION DATE AND UDI #: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE LENS HAS BEEN EXPLANTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS REMAINS IMPLANTED. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURING DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. LINDHOLM, H.R., LAINE, I. & TUUMINEN, R. (2020). INTRACULAR LENS POWER, MYOPIA, AND THE RISK OF ND:YAG CAPSULOTOMY AFTER 15,375 CATARACT SURGERIES. JOURNAL OF CLINICAL MEDICINE. (9), 3071; DOI:10.3390/JCM9103071. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: INTRAOCULAR LENS POWER, MYOPIA, AND THE RISK OF ND:YAG CAPSULOTOMY AFTER 15,375 CATARACT SURGERIES A RETROSPECTIVE COHORT STUDY WAS DONE TO EVALUATE THE REAL-WORLD 5-YEAR PROBABILITY OF ND:YAG CAPSULOTOMY ACCORDING TO THE DIOPTER POWER OF THE IMPLANTED HYDROPHOBIC ACRYLIC MONOFOCAL IOL. A TOTAL OF 15,375 EYES WERE INCLUDED IN THE STUDY AND UNDERWENT PHACOEMULSIFICATION CATARACT SURGERY AND IN-THE-BAG IMPLANTATION OF EITHER ZCB00/PRELOADED PCB00 (N=6,579; ABBOTT MEDICAL OPTICS/JOHNSON & JOHNSON VISION INC), SN60WF/PRELOADED AU00T0 (N=7,098; ALCON), OR ZA9003 IOLS (N=1,698; ABBOTT MEDICAL OPTICS/JOHNSON & JOHNSON VISION INC.). A TOTAL OF 1,312 EYES WERE REQUIRED TO UNDERGO ND:YAG CAPSULOTOMY AS INTERVENTION DUE TO DECREASED CORRECTED DISTANCE VISUAL ACUITY AND DECREASED VISUAL FUNCTION SECONDARY TO POSTERIOR CAPSULE OPACIFICATION (PCO). IT WAS ALSO REPORTED THAT IMPLANTATION OF ZCB00/PCB00 IOLS INCREASES THE RISK OF CAPSULOTOMY. IT IS NOT CLEAR HOW MANY EYES IMPLANTED WITH ZCB00/PRELOADED PCB00 OR ZA9003 DEVELOPED PCO. A SEPARATE REPORT IS BEING SUBMITTED FOR LENS MODEL ZA9003 AND ONE FOR MODEL ZCB00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591603 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention