BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 6615294 · Received June 6, 2017

    Report

    Report Number
    9614546-2017-00499
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    November 2, 2016
    Report Date
    August 1, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    UDI-DI
    05050474560178
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT REVEALED THAT HE CAN ACTUALLY SEE THE REFLECTIVE TRANSMITTANCE DURING USE OF HIS BLACK LIGHT, BUT THESE DAYS HE NEEDS THE HELP OF AMBER COLORED LENSES TO VISUALIZE THEM VERSUS PRIOR TO SURGERY, WHICH HE DID NOT REQUIRE THE AMBER LENSES. THE ONLY ISSUE HE HAS NOW IS EVEN WITH THE HELP OF AMBER COLORED LENSES, HE STILL CANNOT DISTINGUISH BETWEEN NEW AND OLD STAINS. THE INTRAOCULAR LENS HAVE A CUT OFF TRANSMISSION OF APPROXIMATELY 380NM AND REFLECTED TRANSMITTANCE OF FLUORESCENCE OF HIS WORK WILL BE IN THE VISIBLE BLUE TO YELLOW RANGE OF THE SPECTRUM. THE PATIENT WAS HAPPY WITH THE IMPLANTED INTRAOCULAR LENS OVERALL, BUT WOULD OBVIOUSLY LIKE TO REMAIN COMPETENT AT HIS JOB. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    REPORTEDLY, A PATIENT WHO IS A CARPET CLEANER REPORTED THAT HE COULD NOT SEE UNDER ULTRA VIOLENT (UV) LIGHTS WHEN DOING INSPECTION AS PART OF HIS JOB. THE SYMPTOMS BEGAN AFTER THE PATIENT HAD HIS SECOND LENS IMPLANT ON (B)(6) 2016. ACCORDING TO THE CLINICAL SITE, IT WAS RECOMMENDED THAT THE PATIENT SHOULD TRY TO USE A DIFFERENT UV BLACK LIGHT (SOMETHING THAT EXCEEDS 40 NANOMETER). WHEN THE PATIENT RETURNED FOR A FOLLOW UP IN (B)(6) 2017, THE PATIENT DID NOT MENTION ANYTHING ABOUT HIS UV BLACK LIGHT ISSUE. THE PATIENT WAS MEASURED AND OVERALL, HIS VISION WAS PERFECT. THE FOLLOW UP PROVIDED STATED THAT THERE WAS NO PLAN TO EXPLANT THE LENSES, ESPECIALLY SINCE THE LENS HAS BEEN IMPLANTED FOR A WHILE NOW AND THAT THE PATIENT DID NOT REALLY HAVE A CONCERN DURING HIS LAST FOLLOW UP VISIT. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396078 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZKB00 05050474560178

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other