BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21857432 · Received April 17, 2025

    Report

    Report Number
    3012236936-2025-000106
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 20, 2025
    Report Date
    October 10, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810778
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE HAS NOT BEEN EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE PRODUCT INVESTIGATION WAS COMPLETED AND NOTED THAT THE LENS WAS RETURNED. THIS INDICATES THE IOL WAS EXPLANTED. WE FOLLOWED-UP WITH THE CUSTOMER TO ASK ABOUT THE EXPLANT DATE BUT THE INFORMATION WAS NOT PROVIDED. THIS CURRENT REPORT PROVIDES THE UPDATED DETAILS INCLUDING THE INVESTIGATION RESULTS. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED HEALTH EFFECT - IMPACT CODE 4629 - DEVICE REVISION OR REPLACEMENT CAPTURES EXPLANTED LENS SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JUN 18, 2025. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE LENS WAS VISUALLY INSPECTED UNDER MAGNIFICATION REVEALING THAT THE LENS WAS COATED IN VISCOELASTIC RESIDUE WITH ONE HAPTIC DETACHED AND MISSING. THE LENS WAS CLEANED AND INSPECTED. NO FURTHER ISSUES WERE IDENTIFIED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE CUSTOMER PROVIDED ADDITIONAL DETAILS. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED (B)(6)2025. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. CONFIRMED THE PATIENT¿S DATE OF BIRTH IS (B)(6)1965. THIS CURRENT REPORT IS TO PROVIDE THIS INFORMATION. SECTION A2, DATE OF BIRTH: (B)(6)1965. SECTION D6B, IF EXPLANTED, GIVE DATE: (B)(6)2025. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. THE JOHNSON AND JOHNSON INVESTIGATION TEAM COMMENTED THE FOLLOWING REGARDING THE INTRAOCULAR LENS (IOL) THAT HAD BEEN RETURNED AND REPORTED IN MANUFACTURER REPORT NUMBER 12236936-2025-0001061, FOLLOW-UP #1. COMMENT: SINCE IT CANNOT BE DETERMINED WHICH INVESTIGATION THIS LENS BELONGS TO MANUFACTURER REPORT NUMBER 12236936-2025-0001061 OR MANUFACTURER REPORT NUMBER 3012236936-2025-0001062. THE LENS WILL BE EVALUATED IN BOTH INVESTIGATIONS. NOTE. THE INVESTIGATION RESULTS FOR MANUFACTURER REPORT NUMBER 12236936-2025-0001061 WERE ALREADY REPORTED IN FOLLOW-UP #1 OF MANUFACTURER REPORT NUMBER 12236936-2025-0001061. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED ABOUT THE PRELOADED JOHNSON AND JOHNSON (JNJ) ODYSSEY INTRAOCULAR LENS (IOL). THE CUSTOMER HAD A PATIENT THAT IS EXTREMELY UNHAPPY WITH HIS VISION WITH THE ODYSSEY LENS TO THE POINT THAT THE PATIENT HAS HAD A TERRIBLE CAR ACCIDENT. THE SURGEON'S PLAN IS TO EXCHANGE HIS IOLS AND REPLACE THEM WITH VIVITY (A NON JOHNSON AND JOHNSON IOL). THE EXPLANTS HAVE NOT OCCURRED HOWEVER, THE SYMPTOMS WERE REPORTED AS DEBILITATING AS THERE ARE SEVERAL ACTIVITIES THAT THE PATIENT CAN NO LONGER PERFORM THAT THEY COULD PRIOR TO THE SURGERY. SOME OF THE ACTIVITIES ARE DRIVING, MOTORCYCLING AND READING. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAYS IN PROCEDURE. THE END-USER DID NOT SEEK MEDICATION ATTENTION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787607 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other