BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 19869827 · Received July 31, 2024

    Report

    Report Number
    1119421-2024-01455
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    April 26, 2024
    Report Date
    November 7, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 (DAT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K)) (P930014). 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

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE LENS REMAINS IMPLANTED. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION WAS PROVIDED THAT CENTRATION /ALIGNMENT WAS GOOD. NO COMPLICATIONS DURING AND AFTER OPERATION. TEAR FILM WAS ALSO GOOD. THE PROBLEM IS WITH BOTH EYES. 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 HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAVE GOOD VISION FOR DISTANCE, ABSENCE OF INTERMEDIATE VISION. PATIENT CANNOT CUT NAILS, EATING ON PLATE IS BLURRY, MAQUILLATION IMPOSSIBLE, CUTTING VEGETABLES DIFFICULT, DOES NOT SEE HERSELF IN THE MIRROR. THE PATIENT WAS FURTHER SUGGESTED FOR LENS EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. VISION: OS: 10/10 WITH 0.00 (-0.50 TO 70), READ PARIN 1.5. REFRACTION: OS: 0.00 ( -0.50 TO 70 ). INTERMEDIARY ADD +1.50. READING 30-40 CM ADD +2.75.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459171 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15616931

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other