BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 17477279 · Received August 7, 2023

    Report

    Report Number
    3012236936-2023-01918
    Event Type
    Injury
    Date Received
    August 7, 2023
    Report Date
    August 7, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 64.64 (6.67 SD). SECTION A3: 31 FEMALE (47%) AND 35 MALE (53%) PATIENTS. SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS AUGUST 20, 2022. SECTION D4: CATALOG NUMBER: COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A, LENSES REMAINS IMPLANTED. SECTION H3 - OTHER (81): THE IMPLANTS WERE NOT RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE 3191: UNSPECIFIED ISSUE CAUSING REPORTED SYMPTOMS. CITATION: GIMÉNEZ-CALVO, G.; DE ASÍS BARTOL-PUYAL, F.; ALTEMIR, I.; MÉNDEZ-MARTÍNEZ, S.; ALMENARA, C.; SORIANO-PINA, D.; MURUETA-GOYENA, A.; MANUEL LARROSA, J.; INFLUENCE OF OCULAR BIOMETRIC FACTORS ON THE DEFOCUS CURVE IN AN ENLARGED DEPTH-OF-FOCUS INTRAOCULAR LENS; INT OPHTHALMOL (2023) 43:945¿955, HTTPS://DOI.ORG/10.1007/S10792-022-02496-Y. 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: INFLUENCE OF OCULAR BIOMETRIC FACTORS ON THE DEFOCUS CURVE IN AN ENLARGED DEPTH-OF-FOCUS INTRAOCULAR LENS A PROSPECTIVE STUDY WAS DONE TO ASSESS THE INFLUENCE OF BIOMETRIC MEASUREMENTS ON THE DEFOCUS CURVE AFTER THE IMPLANTATION OF ENLARGED DEPTH-OF-FOCUS (EDOF) INTRAOCULAR LENS (IOL). A TOTAL OF 131 EYES OF 66 PATIENTS WITH BILATERAL CATARACTS UNDERWENT PHACOEMULSIFICATION CATARACT SURGERY AND TECNIS SYMFONY ZXR00 IOL (ABBOTT LABORATORIES) IMPLANTATION. AT 6-MONTHS FOLLOWUP UP, IT WAS REPORTED THAT 7.7% OF PATIENTS EXPERIENCED GLARE AND 13.2% OF PATIENTS EXPERIENCED HALOS. ADDITIONALLY, 4% OF PATIENTS WERE NOT SATISFIED WITH THE RESULTS, 14.5% OF PATIENTS HAD DIFFICULTIES IN NEAR VISION, 9.5% OF PATIENTS STILL HAS DEPENDENCE OF REFRACTIVE CORRECTION AND 66% REPORTED HAVING DIFFICULTY DRIVING. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466870 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other