BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20139269 · Received September 4, 2024

    Report

    Report Number
    3012236936-2024-000237
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 25, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474686991
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4 AND A5: UNKNOWN/ASKED BUT NOT AVAILABLE. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 08/22/2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE LENS WAS CUT IN HALF. THE LENS WAS CLEANED AND PRESENTED WITH NO FURTHER ISSUES. NO FURTHER EVALUATION WAS PERFORMED. CONCLUSION: THE COMPLAINT ISSUE BLURRY 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. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TWO PRELOADED INTRAOCULAR LENSES(IOL) WERE IMPLANTED AND EXPLANTED FROM THE LEFT EYE OF THE PATIENT. THE FIRST LENS (ZKU150U185, S/N (B)(6) WAS IMPLANTED IN THE PATIENT'S EYE AND EXPLANTED DUE TO BLURRY VISION AND REPLACED WITH SAME MODEL AND DIOPTER LENS (S/N: (B)(6) IN A SECONDARY PROCEDURE. THE PATIENT COMPLAINED OF BLURRY VISION WITH THE REPLACED SECOND LENS TOO. THE REPLACED SECOND LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THERE WERE NO PATIENT ISSUES. PLATINUM CARTRIDGE WAS USED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833665 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZKU150 05050474686991

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention