BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 19212184 · Received April 30, 2024

    Report

    Report Number
    1119421-2024-00815
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 1, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422871
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (FILL IN APPLICABLE PRODUCT MODEL INFORMATION T3-T6 MODELS) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014)) THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED, THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCT INFORMATION WAS NOT PROVIDED. THE ROOT CAUSE CANNOT BE DETERMINED, FOR THE REPORTED COMPLAINT. THE LENS REMAINS IMPLANTED. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER AND OPTICAL RESOLUTION, DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY, PER THE LENS MODEL AND DIOPTER. DUE DILIGENCE, HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUEST FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED, IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10: REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11 THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCT INFORMATION WAS NOT PROVIDED. THE ROOT CAUSE FOR THE EVENT WAS REPORTED TO BE DUE TO CAPSULE FOLDS. THE PATIENT HAD PREVIOUS LASIK. FURTHER INFORMATION INDICATED THAT A CAPSULOTOMY WAS PERFORMED. THE REPORTED COMPLAINT APPEARS TO BE UNRELATED TO THE LENS. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT SHE HAD UNDERGONE INTRAOCULAR LENS (IOL) IMPLANTATION, BECAUSE HER LASER OPERATION AROUND 2 YEARS AGO WAS NOT SUCCESSFUL. SHE WAS PROMISED THAT HER DISTANCE VISION AND INTERMEDIATE VISION WOULD BE FINE WITH THIS LENS AND THERE WILL BE NO DIFFICULTY WITH RAYS OF LIGHT. HOWEVER, AFTER IMPLANTATION, SHE EXPERIENCED THAT HER VISION WAS BLURRY FROM AROUND 3 METERS AWAY. SHE COULD NOT READ ANYTHING OR SEE FACES CLEARLY FROM A DISTANCE OF 3 METERS. SHE WAS VERY UNCOMFORTABLE WITH THE RAYS OF LIGHT IN THE DARK. SINCE THEN SHE HAD NOT BEEN ABLE TO DRIVE A CAR ANYMORE. SHE RECOGNIZED LARGE TRAFFIC SIGNS SHORTLY BEFOREHAND. THERE WAS NO IMPROVEMENT IN 10 WEEKS. WHEN IT WAS BRIGHT, SHE COULD NOT SEE CONTRAST. THE LENS REMAINS IMPLANTED. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE CONSUMER SAW LASER SPECIALIST TWO YEARS AGO AND HAD LASER SURGERY ON BOTH EYES. HER LASER SPECIALIST SUGGESTED HER TO IMPLANT THIS LENS TO RESOLVE HER SYMPTOMS. HOWEVER, TO THIS DAY, SHE IS UNCOMFORTABLE WITH LIGHT RAYS, SHE HAS GLARE, AND OUT OF FOCUS INTERMEDIATE AND DISTANCE VISION. SHE CAN ONLY SEE IN THE NEAR WITHOUT ANY PROBLEM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

    Description of Event or Problem · 0

    IN THE SURGEON'S OPINION CAPSULE FOLDS ATTRIBUTED TO THE EVENTS. LATER CAPSULOTOMY HAD TO BE PERFORMED BECAUSE OF THAT. THE LENS REMAINS IN THE EYE, NO EXPLANTATION HAS BEEN PLANNED. THE PATIENT ALSO HAD A HISTORY OF LASIK PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143386 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15368939 00380652422871

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other