BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18577100 · Received January 24, 2024

    Report

    Report Number
    3012236936-2024-00189
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    November 28, 2023
    Report Date
    January 24, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474751828
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, A5: UNKNOWN/ NOT PROVIDED. ASKU. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. 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, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED THEN REMOVED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE DUE TO BAG INTEGRITY "BAG NO LONGER ABLE TO SUPPORT LENS". THE REPLACEMENT IOL USED WAS A SULCUS LENS, 1.0 DIOPTER LOWER POWER SIZE THAN THE ORIGINAL IOL (AR40E +17.5). HOWEVER, IT WAS NOTED BY THE CUSTOMER THAT THERE WAS NO PRODUCT QUALITY ISSUE, NO USE ERROR. IT WAS ALSO NOTED THAT PATIENT WAS DOING WELL THE FOLLOWING DAY, NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. OPHTHALMIC VISCOSURGICAL DEVICES (OVD) WAS USED, AND IT WAS ALLOWED TO ACCLIMATIZE IN OPERATING ROOM TEMPERATURE AS WELL AS THE BALANCED SALT SOLUTION (BSS) USED. THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191487 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFW225 05050474751828

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention