BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18162216 · Received November 17, 2023

    Report

    Report Number
    3012236936-2023-02759
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 18, 2023
    Report Date
    November 17, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A4 : UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED. SECTION E1 - (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 - OTHER (81): 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYMPTOM SUSPECTED TO BE ENDOPHTHALMITIS HAD DEVELOPED AFTER THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL) ON THE FIST POSTOPERATIVE DAY, WHICH INTERFERED WITH ACHIEVING THE AIMED VISUAL ACUITY. THE IOL REMAINS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED, THAT DAILY ACTIVITIES WERE NOT AFFECTED AND THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) AFTER SURGERY WAS 1.0 AND AFTER ONE WEEK POST-OPERATION WAS 0.6. NO PROBLEMS WERE IDENTIFIED DURING THE HAND SANITATION BY THE HEALTHCARE PROFESSIONALS. NO MEDICAL INTERVENTIONS ARE PLANNED AND THE PHYSICIAN WILL MONITOR IT'S PROGRESSION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917412 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other