BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20799970 · Received November 27, 2024

    Report

    Report Number
    3012236936-2024-000310
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 8, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655447
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G3 - DATE RECEIVED BY MANUFACTURER: 13-DEC-2024 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. PHOTOS PROVIDED BY THE CUSTOMER WERE EVALUATED BY A POST MARKET SAFETY SURVEILLANCE OFFICER. THE PHOTOS SHOW AN EYE BEING IMPLANTED WITH AN INTRAOCULAR LENS. A BLACKISH/GRAYISH PARACENTRAL SPOT CAN BE OBSERVED. ALTHOUGH PER THE LOCATION OF THE SPOT IT IS POSSIBLE TO CAUSE SOME VISUAL DISTORTIONS IN THE EVENT THE LENS REMAINS IMPLANTED, ITS ACTUAL CLINICAL IMPACT AND POTENTIAL ROOT CAUSE CANNOT BE DETERMINED FROM A PICTURE ASSESSMENT. THE COMPLAINT ISSUE "COSMETIC ISSUES" WAS IDENTIFIED DURING PHOTO EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE CENTRAL MARKS ON THE INTRAOCULAR LENS (IOL). IT WAS REPORTED THAT THE ISSUE WAS IDENTIFIED AFTER IMPLANTATION. THROUGH FOLLOW UPS IT WAS CONFIRMED THAT THE MARKS ON THE LENS ARE CIRCULAR AND THAT THE LENS WILL REMAIN IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832206 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown