BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20765188 · Received November 22, 2024

    Report

    Report Number
    3012236936-2024-000313
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 22, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746787
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3A, A3B, A4, A5: UNKNOWN/ NOT PROVIDED. ASKU. SECTION D6A: IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. SECTION H3- NO: THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS LENS WAS DISCARDED; 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. AN ATTEMPT HAS 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) HAD TO BE EXPLANTED DUE TO THE IOL BEING SCRATCHED. THE SURGERY TIME WAS EXTENDED. IT WAS REPLACED WITH SAME MODEL AND DIOPTER SIZE IOL. THERE WAS NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY, NO MEDICATION OUTSIDE OF STANDARD OF CARE. THEY USED ONLY BALANCED SALINE SOLUTION (BSS) IN ROOM TEMPERATURE AS LUBRICANT, INTRODUCED FROM THE CARTRIDGE CANOPY, AVERAGE DWELL TIME WAS 3 MINUTES, THE SCRUB TECH PERFORMED THE INITIAL MOVEMENT MAKING SMALL 1/4 TWISTS, NO PHOTOS OR VIDEOS CAN BE PROVIDED, NO PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594392 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746787

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown