BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19307317 · Received May 14, 2024

    Report

    Report Number
    3012236936-2024-000130
    Event Type
    Injury
    Date Received
    May 14, 2024
    Report Date
    May 13, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474579095
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4, A5/A6: UNKNOWN/ NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATE IS UNKNOWN/NOT PROVIDED. BEST ESTIMATE DATE IS ON OR AFTER APR 19, 2022. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION H3-NO: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; 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 A FEMALE PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, BUT VISION IS NOW WORSE THAN EVER. THE PATIENT COMPLAINED TO DOCTOR ABOUT SEEING STARBURSTS AROUND CAR LIGHTS AND AURAS AROUND LIGHTS/STARS/THE MOON AT NIGHT. PATIENT COULD NO LONGER DRIVE COMFORTABLY AFTER DUSK. THE DOCTOR ASSURED PATIENT THAT IT SHOULD IMPROVE, AND THAT WHAT SHE WAS EXPERIENCING WAS ONLY TEMPORARY, AND SAID TO GIVE IT TIME. THE PATIENT DID, AND NOW, TWO YEARS LATER, VISION HAS NOT IMPROVED AND IF ANYTHING HAS GOTTEN WORSE. PATIENT NOW NOTICES/SEES AN AURA AROUND ANYTHING LIGHT OR BRIGHT. THESE HAPPEN WITH BOTH EYES EVEN DURING THE DAY. CAN SEE AURAS AROUND HER COMPUTER, THE TV, HER HAND, HER SILVERWARE AS SHE EATS, THE GLASS OF WATER NEXT TO HER COMPUTER, ETC. AT NIGHT VISION IS SIGNIFICANTLY WORSE AND THE PATIENT CAN NO LONGER DRIVE AFTER DUSK. IT NOW APPEARS THAT THE VISION ISSUE IS NOW PERMANENT. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD) OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520927 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00 05050474579095

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other