BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 19711498 · Received July 10, 2024

    Report

    Report Number
    1119421-2024-01294
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422819
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 (DFT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN D.4. ADDITIONAL INFORMATION WAS 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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE LENS REMAINS IMPLANTED. EACH LENS IS SUBJECTED TO A 100 PERCENTAGE ASSESSMENT OF THE POWER AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION CONTAINED IN THE FOLLOW UP DETAILS OF THE FILE INDICATED THAT COMPANY INFORMED THE CUSTOMER THAT BECAUSE THE INTRAOCULAR LENS IS IMPLANTED, IT IS NOT POSSIBLE TO CARRY OUT AN INVESTIGATION OF THE SAMPLE ITSELF, ONLY A DOCUMENTARY INVESTIGATION OF THE BATCH COMPLAINED OF. THE PATIENT WAS THE REPORTER. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, CANT READ A LINE AND VISION WAS DOUBLED. THE PATIENT UNDERGONE A CAPSULOTOMY PROCEDURE AND THERE'S BEEN NO IMPROVEMENT AND SEEING LESS THAN BEFORE THE LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT EXPERIENCED LOW VISION, DISCOMFORT, RED EYE, HEAVY EYE, HAZE, AND UNCOMFORTABLE WITH GLASSES. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATE THAT THE PATIENT SAYS THERE IS NO PROBLEM WITH THE ADAPTATION AS SHE HAD THE SURGERY 3 MONTHS AND 11 DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149835 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15344629 00380652422819

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention