BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12333723 · Received August 17, 2021

    Report

    Report Number
    2648035-2021-08309
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    December 1, 2020
    Report Date
    October 6, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474579101
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEWING THE SUPPLEMENTAL MDR 2648035-2021-08309, IT WAS NOTICED THAT THE FOLLOWING INFORMATION WAS INADVERTENTLY NOT INCLUDED; THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT: SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) SECTION B3: DATE OF EVENT: 12/1/2020 SECTION H3-81 (OTHER): THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT IS DISCARDED; 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 WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4629 SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS EXPERIENCING SEEING STARBURSTS AND BIG RINGS AROUND LIGHTS. WHEN THE PATIENT WAS DRIVING AT NIGHT, THE VISUAL ISSUES WERE SO DEBILITATING, SHE STOPPED DRIVING AFTER THAT. IT WAS LEARNED THAT THE LENS WAS EXPLANTED IN THE RIGHT EYE A COUPLE WEEKS AGO. THE PATIENT DID NOT HAVE THE EXACT DATE. THE PATIENT DID NOT KNOW WHY TYPE OF REPLACEMENT LENS WAS IMPLANTED AS A REPLACEMENT OR IF IT WAS A JOHNSON & JOHNSON LENS. THROUGH FOLLOW-UP WITH THE PATIENT'S IMPLANTING SURGEON'S OFFICE, IT WAS LEARNED THAT AT THE 1 MONTH POST-OPERATIVE (OP) VISIT, THE PATIENT COMPLAINED THAT SHE COULD NOT SEE CLEARLY. VISUAL ACUITY (VA) 20/25 -2. ON 12/8/2020, THE PATIENT COMPLAINED OF HALOS AND SEEING CONCENTRIC CIRCLES THAT LOOK LIKE A FAN BLADE. VA 20/30-2. ON 1/11/2021, THE PATIENT STILL EXPERIENCED BLURRINESS AND COULD NOT SEE AT NIGHT. THE PATIENT TOLD THE SURGEON SHE NO LONGER DRIVES AT NIGHT AS THE PATIENT STILL SEES STARBURSTS AND BIG CIRCLES. THE SURGEON PRESCRIBED GLASSES AND ARTIFICIAL TEARS. THE PATIENT WAS SUPPOSED TO HAVE ANOTHER FOLLOW-UP APPOINTMENT, HOWEVER, THE PATIENT DECIDED TO SEE A DIFFERENT DOCTOR AT ANOTHER FACILITY. NO OTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP WITH THE PATIENT'S EXPLANT SURGEON'S OFFICE, THE DOCTOR INDICATED THAT THERE WAS NOTHING WRONG WITH THE LENS. THE PATIENT JUST COULD NOT TOLERATE THE THE RINGS, GLARE, AND STARBURSTS. HER VISUAL ISSUES INCREASED AND BECAME SO INTOLERABLE THE PATIENT WANTED TO EXCHANGE THE LENS. WHEN THE LENS WAS EXPLANTED, IT WAS CUT UP IN HALF AND DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY (OP). THE PATIENT'S WEIGHT WAS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION A4/:WEIGHT: UNKNOWN/ASKED BUT UNAVAILABLE. SECTION: A5: RACE: WHITE, ETHNICITY: NOT HISPANIC/LATINO SECTION D6B: IF EXPLANTED; GIVE DATE: 7/7/2021 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PT INFO: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE LENS HAS BEEN EXPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; 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 WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING COMPLICATIONS SUCH AS SEEING STARBURST, BIG CIRCLES, AND CANNOT DRIVE. THE PATIENT ALSO REPORTED SEEING STRAIGHT LINES ABOVE THE CIRCLES. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227162 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 05050474579101

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R