BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 22303265 · Received June 20, 2025

    Report

    Report Number
    3012236936-2025-000166
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    January 18, 2024
    Report Date
    June 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474728868
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 - HEALTH EFFECT - CLINICAL CODE: 4581: NO CODE AVAILABLE (DEVICE DISLOCATION) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT COMPLICATIONS AROSE DURING THE SURGERY OF THE FIRST EYE OF A PATIENT. THE CUSTOMER INDICATED THAT A SECONDARY IMPLANT WAS NECESSARY FOLLOWING THE INITIAL PROCEDURE. UPON INQUIRY, IT WAS CONFIRMED THAT A JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) WAS USED. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT UNDERWENT A FACECTOMY IN THE RIGHT EYE, AFTER THE REMOVAL OF THE IOL BY PHACOEMULSIFICATION. IT WAS OBSERVED A PERIPHERAL REGION WITH RESIDUAL CORTEX AND REDUCTION OF LOCAL TRANSPARENCY. AFTER REMOVAL OF THE CORTEX, IT WAS OBSERVED THE PRESENCE OF FIBROSIS JOINING THE POSTERIOR AND ANTERIOR CAPSULE, GENERATING DECENTRATION OF THE IOL. THE DOCTOR DECIDED TO REMOVE IT AND PLAN A SECONDARY IMPLANT OF A HYDROPHOBIC SPHERE MONOFOCAL IOL. THE CORTEX WAS REMOVED AFTER THE IMPLANT. IT WAS MENTIONED THAT THE IOL WAS IMPLANTED FIRST AND THEN THE PHYSICIAN REMOVED THE REMAINING CORTEX. THE LENS WAS REMOVED IN THE SAME DATE. A 3 PIECE IOL FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THE REPLACEMENT LENS WAS IMPLANTED AT A DIFFERENT DATE. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207527 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU450 05050474728868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention