BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18716801 · Received February 15, 2024

    Report

    Report Number
    3012236936-2024-00371
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 9, 2024
    Report Date
    March 6, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655485
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT SEES WELL AT A DISTANCE WITH CORRECTION, USING -0.75. THE SURGEON WOULD LIKE TO KNOW IF THERE WAS A BIOMETRIC ERROR. IT WAS CONFIRMED THAT THE PRE-OPERATIVE VISUAL ACUITY OF 20/30 J1 WAS BEST CORRECTED AND POST-OPERATIVE VISUAL ACUITY OF 20/20 J1 WAS BEST CORRECTED. THE PRODUCT SERIAL NUMBER WAS ALSO RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION D4: CATALOG NUMBER: DIB00I0240. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: MAY 9, 2026. SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SECTION H3 - OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: MAY 9, 2023. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT COMPLAINED ABOUT DISTANCE VISION, MENTIONING THAT WHEN DRIVING, BETWEEN THE PATIENT'S CAR AND THE CAR IN FRONT, IT "FEELS LIKE THERE ARE SHADOWS". THE PATIENT ALSO COMPLAINED OF HAVING DIFFICULTY SEEING PEOPLE FROM A DISTANCE. PRE-OPERATIVE VISUAL ACUITY WAS 20/30, J1 AND POST-OPERATIVE VISUAL ACUITY IS 20/20, J1. REFRACTION IS -0.75. IT IS NOTED THAT THERE IS A DAILY ACTIVITY THAT THE PATIENT CANNOT PERFORM AND WAS ABLE TO PRIOR TO SURGERY, WHICH IS SEEING FAR AWAY. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. THERE WAS NO DELAY IN PROCEDURE. IT WAS NOTED THAT DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION NOR WAS ANY MEDICATION PRESCRIBED OUTSIDE OF THE STANDARD OF CARE. THE PRODUCT IS NOT AVAILABLE, AS THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126233 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655485

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other