BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18107183 · Received November 9, 2023

    Report

    Report Number
    3012236936-2023-02844
    Event Type
    Injury
    Date Received
    November 9, 2023
    Report Date
    November 26, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474688933
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: NOV 7, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE OF A SPECIMEN VIAL. NO ADDITIONAL MATERIALS WERE RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT BUT NOT INTO SEPARATE PIECES. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE COMPLAINT ISSUES "EXPLANT", "SUTURES", AND "VISUAL DISTURBANCE- DYSPHOTOPSIA" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2022 AND (B)(6) 2023. 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 - IMPACT CODE: 4625 -SUTURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TORIC MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO VISUAL DISTURBANCES AND MULTIFOCAL INTOLERANCE. THE INCISION WAS ENLARGED, AND ONE SUTURE WAS USED. A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. NO OTHER SURGICAL INTERVENTIONS REPORTED. THE PATIENT IS GOOD AND NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804924 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZKU375 05050474688933

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention