BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 9113020 · Received September 24, 2019

    Report

    Report Number
    2648035-2019-01036
    Event Type
    Injury
    Date Received
    September 24, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531796
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS LENS HAS NOT BEEN EXPLANTED. (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT CANNOT BE RETURNED SINCE IT REMAINS IN THE PATIENT'S EYE. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZCB00 LENS 24.0 DIOPTER LENS WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. SHE CAN SEE HALF-MOON SHADOWS IN HER LEFT PERIPHERAL VISION. HER EYES ARE SWOLLEN FROM THE SURGERY AND SHE IS EXPERIENCING RED, WATERY, SORE EYES WITH STABBING PAIN. HER DOCTOR PRESCRIBED STEROID DROPS. IN ADDITION, SHE STILL NEEDS TO WEAR TRI-FOCALS. PER THE PATIENT, HER DOCTOR SAID THERE¿S A FILM DEVELOPING OVER THE LENS. THE DOCTOR RECOMMENDED LASER SURGERY WHICH IS SCHEDULED FOR (B)(6) 2019. PER FOLLOW-UP WITH THE PATIENT SHE SAID THAT IN HER OPINION THERE IS SOMETHING WRONG WITH THE LENS. SHE CONSTANTLY SEES HAZE, LIGHTS, AND RINGS. THE PATIENT EXPLAINED THAT SHE DOES NOT HAVE THE PERIPHERAL VISION SHE USED TO HAVE BEFORE SHE GOT THE IOLS IMPLANTED. THE PATIENT COMPLAINED OF STILL NEEDING TO WEAR READING GLASSES. NO FURTHER INFORMATION WAS PROVIDED. THE RIGHT EYE WILL BE REPORTED IN A SEPARATE MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906747 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention