BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20827770 · Received December 2, 2024

    Report

    Report Number
    3012236936-2024-000310
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 7, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    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. THE CUSTOMER PROVIDED A PHOTO WAS EVALUATED BY A POST MARKET SAFETY SURVEILLANCE OFFICER. THE PHOTO SHOWS AN EYE BEING IMPLANTED WITH AN INTRAOCULAR LENS. A TRIANGULAR SHAPE CRACK-LIKE MARK CAN BE OBSERVED IN THE LENS PERIPHERY AND MID PERIPHERY (AT 12:30 IN RELATION TO THE PICTURE ORIENTATION). THE LOCATION OF THE ISSUE MAY IMPACT PATIENT VISUAL FUNCTION IF THE LENS REMAINS IMPLANTED; HOWEVER, THE DEFINITIVE CLINICAL IMPACT AND THE INCIDENTAL ROOT CAUSE CANNOT BE DETERMINED FROM A PICTURE ASSESSMENT. THE COMPLAINT ISSUE "LENS DAMAGED" 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.

    Additional Manufacturer Narrative · 0

    SECTION 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 G4 - PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE WHEN IT CAME OUT OF THE SHOOTER. THE ISSUE WAS NOTICED AFTER IMPLANTATION. IT WAS REPORTED THAT THE LENS REMAINS IMPLANTED. THE SHOOTER WAS DISCARDED. THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) USED WERE HEALON PRO AND BALANCED SALT SOLUTION (BSS). NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470227 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown