BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22066996 · Received May 21, 2025

    Report

    Report Number
    3012236936-2025-000144
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Report Date
    June 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636064
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THERE WAS NO PATIENT CONTACT. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF STANDARD OF CARE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367822 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown