BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20562225 · Received October 29, 2024

    Report

    Report Number
    3012236936-2024-000286
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Report Date
    January 6, 2025
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A3B, A4 AND A5: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION B3: DATE OF EVENT: UNKNOWN, 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. SECTION E1:SURGEON'S EMAIL ADDRESS AND PHONE NUMBER: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION H3: 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THE MEDICAL DEVICE PROBLEM CODE: 1069- DC-LENS DAMAGED REPORTED IN THE INITIAL REPORT DOES NOT APPLY AND IS NO LONGER APPLICABLE AND THE EVENT IS NO LONGER CONSIDERED REPORTABLE. HENCE A CORRECTION REPORT WOULD BE SUBMITTED FOR US WITH AWARE DATE BEING 12/18/2024, THE DATE OF REASSESSMENT. THEREFORE, NO FURTHER INFORMATION WILL BE SUBMITTED UNDER MEDWATCH 3012236936-2024-0002868. 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 INTRAOCULAR LENS (IOL) WAS RECEIVED WITH THE OUTER SHIPPING BOX AND THE INNER LENS BOX DAMAGED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318389 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown