BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 9550349 · Received January 6, 2020

    Report

    Report Number
    2648035-2020-00012
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    July 19, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531574
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE LENS REMAINS IMPLANTED. (B)(4). DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PREFORMED BECAUSE PER THE INITIAL REPORT THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED THIS PRODUCTION ORDER (PO) WAS PERFORMED. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PO NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF A MODEL ZCB00 INTRAOCULAR LENS (IOL), PATIENT EXPERIENCED SYMPTOMS OF BLURRY VISION, MILKY VISION AND COLOR CHANGES, LIKE WHITE DOGS ARE PURPLE AND BLACK DOGS ARE DARK BLUE. WHEN SHE WAS FIRST IMPLANTED, SHE FELT LIKE THERE WAS BRIGHT LIGHT ALL THE TIME AND NEEDED TO USE YELLOW TINTED SUNGLASSES. WHEN THE SUN IS OUT NOW THE SHE FEELS LIKE SHE IS IN UV LIGHT (PURPLE). WHEN READING SHE FINDS THE TEXT PALE GRAY, LIKE SHE IS WEARING DIRTY GLASSES. THE SURGEON HAS TOLD HER THAT THERE IS A SLIGHT POSTERIOR CAPSULE OPACIFICATION (PCO) BUT NOT MUCH. THE PATIENT THINKS THERE IS SOMETHING WRONG WITH THE IMPLANT. ADDITIONAL INFORMATION STATES THE SURGEON COULD TELL US THAT THE PATIENT ALREADY HAS PROBLEMS WITH THE OPERATED EYE THAT HAS NOTHING TO DO WITH THE IMPLANT, THERE IS ALSO QUITE A LOT OF PCO THAT HE WILL NOT REMOVE YET IF HE NEEDS TO EXPLANT THE IOL. FURTHER INFORMATION PROVIDED, PATIENT HAS HAD GOOD VISUAL ACUITY (VA) 20/20 FROM THE DAY AFTER SURGERY BUT COMPLAINS OF POOR CONTRAST SENSITIVITY (WHICH HAS NOT BEEN CONFIRMED IN ADEQUATE TESTING), A CHANGED SENSE OF COLOR PERCEPTION WITH A DOMINANCE OF BLUE (COLOR TESTING THOUGH NORMAL). IN A SLIT LAMP VIEW, THE IOL IS PERFECTLY NORMAL. ALL INFORMATION AVAILABLE IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15493 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention