BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12841097 · Received November 18, 2021

    Report

    Report Number
    3012236936-2021-00014
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 18, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636200
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PT INFO: INFORMATION UNKNOWN/NOT PROVIDED. (B)(6). IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. THEREFORE, NOT EXPLANTED. THE INTRAOCULAR LENS (IOL) 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) INJECTOR WAS BROKEN BUT THERE WAS NO IMPACT ON THE PATIENT. ACCOUNT PROVIDED THAT THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE AND RESIDUE FROM A PIECE OF PLASTIC THAT BROKE-OFF GOT INTO THE PATIENT'S OPERATIVE EYE. THE SURGEON WAS ABLE TO PROCEED WITH THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737841 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female