BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18540238 · Received January 18, 2024

    Report

    Report Number
    3012236936-2024-00135
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 17, 2024
    Report Date
    January 24, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731738
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5 PATIENT INFORMATION: INFORMATION UNKNOWN/NOT PROVIDED. 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. THEREFORE, NOT EXPLANTED. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THROUGH FOLLOW-UP. THE CUSTOMER CONFIRMED THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED. THE LENS WAS CUT OUT OF THE LEFT EYE AND DISPOSED OF. THEREFORE, THE CUSTOMER HAS NOTHING TO RETURN. REPORTEDLY, THE CUSTOMER IS NOT SURE HOW THE PATIENT IS DOING POST OPERATIVELY. THE DOCTOR¿S FIRST NAME IS PETER, OFFICE TELEPHONE NUMBER IS (B)(6). NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED. SECTION E1: FIRST/GIVEN NAME: (B)(6). SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H6: TYPE OF INVESTIGATION: 4115 DEVICE DISCARDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED, SCRATCHED. THE IOL WAS NOT LEFT IMPLANTED IN THE EYE. REPORTEDLY, THE LENS WAS OPENED, INSERTED INTO THE OPERATIVE EYE AND THEN REMOVED. THE SURGEON REQUESTED A NEW LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474952 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731738

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male