BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21437684 · Received February 21, 2025

    Report

    Report Number
    3012236936-2025-000052
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 4, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636125
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ISSUE WAS ONLY CARTRIDGE TIP DAMAGE AND NOT LENS DAMAGE. IT WAS STATED THAT THE DOCTOR LOOKED AT THE DCB00 UNDER THE MICROSCOPE AND SAW THAT THE CARTRIDGE TIP WAS CRACKED. THAT THE DEVICE WAS NOT PUT IN THE PATIENT'S EYE AND HAD NO CONTACT AS THE DOCTOR SAW THE ISSUE AND DID NOT USE THE LENS. IT WAS CONFIRMED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ANOTHER LENS OF EXACT MODEL/DIOPTER WAS USED AND SURGERY COMPLETED WITH NO INTERVENTIONS OR INJURY. THE PATIENT IS FINE. IT WAS NOTED THAT THEY USED ONLY BSS AT ROOM TEMPERATURE. THE DWELL TIME IS ABOUT 1 MINUTE. THE INITIAL ADVANCEMENT IS DONE BY THE DOCTOR. IT IS UNKNOWN IF DOCTOR MAKES COMPLETE TURNS OR SMALL ¼ TWIST. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION A2, A3A, A3B, A4, A5 AND A6: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT WITH THE DEVICE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THIS EVENT WAS A DUPLICATE OF AN EARLIER INCIDENT WHICH HAD ALREADY BEEN REPORTED UNDER MANUFACTURER REPORT #3012236936-2025-0000450. UPON FURTHER REPORT AND BASED ON THE ADDITIONAL INFORMATION RECEIVED FORM THE ACCOUNT WHICH INDICATED THAT THE CARTRIDGE CRACK/DAMAGE ISSUE WAS NOTICED PRIOR TO DEVICE BEING PUT IN THE EYE OF PATIENT AND THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE; THEREFORE, THE EVENT NO LONGER MEETS THE REPORTABLE CRITERIA AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 3012236936-2025-0000522. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A: IF IMPLANTED; GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. HENCE, NOT EXPLANTED. SECTION E1: PHONE NUMBER: (B)(6). SECTION H3(NO): THE DEVICE WAS NOT 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN SURGEON WAS GETTING READY TO PUT THE MONOFOCAL INTRAOCULAR LENS (IOL) IN THE EYE HE REALIZED THAT THE TIP ON THE INJECTION WAS SPLIT IN TWO. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543891 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown