BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18103996 · Received November 9, 2023

    Report

    Report Number
    3012236936-2023-02840
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    September 6, 2023
    Report Date
    May 23, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810839
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 04/04/2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE SUSPECT PRODUCT REVEALED THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THEN LENS WAS CLEANED AND INSPECTED AND NO ISSUES THAT COULD CONTRIBUTE TO THE COMPLAINT ISSUE. NO FURTHER EVALUATION WAS PERFORMED. CONCLUSION: THE COMPLAINT ISSUE BLURRY VISION, POOR NEAR VISION, HALO VISION AND EXPLANT WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137- USED TO INDICATE BLURRY VISION AND POOR NEAR VISION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TECNIS ODYSSEY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT UNABLE TO READ SMALL PRINT. THERE WERE NO OTHER MEDICAL/SURGICAL INTERVENTIONS REQUIRED. THE LENS WAS REPLACED WITH A ZLB00 23.5 D LENS IN SECONDARY PROCEDURE. PATIENT IS DOING WELL. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO PATIENT INJURY. PATIENT ALSO HAD HALOS AT NIGHT AND HEATWAVE IN VISION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110892 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention