BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21280206 · Received January 30, 2025

    Report

    Report Number
    3012236936-2025-000023
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 17, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731509
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    . SECTION E1: TELEPHONE NUMBER: (B)(6). 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, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: ADDITIONAL INFORMATION WAS PROVIDED AND REPORTED THE IMPLANT DATE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) SN (SERIAL NUMBER) (B)(6) WAS IMPLANTED AS A REPLACEMENT. NO OTHER NEW INFORMATION PROVIDED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION D6A: IF IMPLANTED, GIVE DATE: (B)(6) 2025. 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 AND THE HAPTIC WAS BROKEN. THE IOL CAME OUT OF THE INJECTOR THIS WAY AND NOT DUE TO INSERTION. THE LENS WAS CUT OFF AND REMOVED FROM THE PATIENT'S OPERATIVE EYE. ANOTHER LENS WAS INSERTED AS A REPLACEMENT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE WAS PERFORMED. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319945 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown