BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16763509 · Received April 18, 2023

    Report

    Report Number
    3012236936-2023-00874
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 2, 2023
    Report Date
    November 29, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731820
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION H3-OTHER (81): THE DEVICE HAS NOT BEEN 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS IS TO CORRECT THE INITIAL SUBMISSION SECTION H6 ADVERSE EVENT PROBLEM. THE HEALTH EFFECT-IMPACT CODE STATED 2199 - NO HEALTH CONSEQUENCES OR IMPACT. BUT THE CORRECT CODE IS 4631 TO CAPTURE REMOVAL AND REPLACEMENT. AND 4632 TO CAPTURE DELAY IN TREATMENT. FIELDS BELOW ARE UPDATED. THE HEALTH EFFECT-IMPACT CODE: 4631 USED TO CAPTURE REMOVAL AND REPLACEMENT AND 4632 TO CAPTURE DELAY IN TREATMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS TO CORRECT THE INITIAL SUBMISSION SECTION B5 STATES ¿HAPTIC WAS NOTICED TO HAVE A MISSING SECTION.¿ THE HAPTIC WAS NOT NOTICED TO BE MISSING A SECTION. CONSEQUENTLY, SECTION H6, MEDICAL DEVICE PROBLEM CODE: 1261 - MATERIAL FRAGMENTATION SHOULD NOT HAVE BEEN INCLUDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE WHEN THE HAPTIC WAS NOTICED TO HAVE A MISSING SECTION. THE LENS WOULD NOT CENTER. THE IOL WAS REMOVED AND REPLACED WITH A BACK-UP LENS OF A DIFFERENT MODEL AND DIOPTER, MODEL ZA9003 22.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO MEDICAL ATTENTION WAS REQUIRED, AND NO MEDICATION (OUTSIDE OF STANDARD CARE) WAS PRESCRIBED. A DELAY IN THE PROCEDURE WAS REPORTED HOWEVER THE LENGTH OF DELAY IS UNKNOWN. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY IS 20/40 -1 AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY IS20/25 -1. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541148 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731820

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female