BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18843055 · Received March 5, 2024

    Report

    Report Number
    3012236936-2024-00585
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 9, 2023
    Report Date
    March 5, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746596
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - HEALTH EFFECT - CLINICAL CODE 4581 USED FOR DEVICE DECENTERED OR DISLOCATED OR TILTED SUBLUXATED OR WRONG POSITION. PRODUCT INVESTIGATION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A RECORD REVIEW WAS PERFORMED AND NO PRODUCT DEFICIENCY IDENTIFIED AS ALL UNITS WERE RELEASED WITHIN SPECIFICATION. BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT TORIC INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2023 IN HER RIGHT EYE AND THE NEXT DAY SHE WAS UNABLE TO SEE. PATIENT EXPLAINED THAT THERE IS A HUGE HALF- MOON SHADOW FROM THE 12 O'CLOCK UNTIL THE 6:00 O'CLOCK AND THAT SHE SAW FIVE LAYERS STACKED. THESE VISUAL PROBLEMS HAD AFFECTED HER FOR THE LAST YEAR. PATIENT IS DISAPPOINTED, UPSET AND REPORTED THAT SHE HAS BEEN TERMINATED FROM A JOB AS A RESULT OF MAKING MISTAKES DUE TO HER VISUAL ISSUES. FEW MONTHS AGO, EYE DROPS WERE PRESCRIBED TO SHRINK EYE PUPIL BUT HIS FAILED AND MADE HER UNSTABLE, DIZZY, NAUSEOUS. GLASSES WERE ALSO TRIED BUT DID NOT WORK. SHE REPORTED THAT HER SURGEON INSISTS THE LENS IS PROPERLY IMPLANTED BUT THAT SHE HAD GONE TO FOUR (4) OTHER EYE SPECIALISTS AND BEEN TOLD BY 3 OF THEM THAT THE LENS IS OUT OF ALIGNMENT. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ DISTANCE VISION ONLY LENS IN A SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103137 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention