BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16313724 · Received February 7, 2023

    Report

    Report Number
    3012236936-2023-00124
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    November 16, 2022
    Report Date
    February 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474574298
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: TELEPHONE NUMBER: (B)(6). 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 WAS PERFORMED. THE MANUFACTURING RECORDS REVIEW SHOWED UNITS WERE RELEASED WITHIN SPECIFICATION. THE LENS DIOPTER RESULTS OBTAINED FROM THE MIQ ELECTRONIC SYSTEM SHOW THAT THIS PO WAS RELEASED WITHIN DIOPTER SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INTRAOCULAR LENS (IOL), INTO THEIR RIGHT EYE WAS VERY UNHAPPY WITH STARBURSTS, HALOS, AND GLARES DESPITE OF AN EXCELLENT UNCORRECTED DISTANCE AND NEAR VISUAL ACUITY. THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT JOHNSON AND JOHNSON LENS (MODEL: DIU150, EYHANCE TORIC) OF THE SAME DIOPTER. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. VISUAL ACUITIES ARE NOT ACCESSIBLE TO PROVIDE. THE IOL IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943388 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXT150 05050474574298

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention