BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 18109891 · Received November 10, 2023

    Report

    Report Number
    9612169-2023-00791
    Event Type
    Injury
    Date Received
    November 10, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    POE
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.10. THE MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER 9612169-2023-00898 DUE TO A CLARIFICATION RECEIVED IN THE INITIAL REPORTER (COUNTRY OF INCIDENCE UPDATED FROM AUSTRALIA TO UNITED STATES). ALL THE FURTHER REPORTS WILL BE REPORTED UNDER 9612169-2023-00898. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT HE HAD SHARED VERBALLY SOME CONCERNS AROUND AN ONLINE FORUM SHE WAS PART OF, WHERE US SURGEONS INCLUDING ALCON KOLS HAVE SHARED THEIR CONCERNS REGARDING LENS OUTCOMES. SOME OF THESE SURGEONS HAVE RETURNED TO ACRYSOF LENS & SHARED THEY HAVE EXPLANTED CLAREON LENSDUE TO WAXY VISION WITH NO CAUSE IDENTIFIED, AND REPLACED WITH ACRYSOF VIVITY WITH IMMEDIATELY BETTER RESULTS. THESE ARE SURGEONS THAT ALSO UTILISE LASIK FOR REFRACTIVE TOUCHUPS SO HAS INTERPRETED THIS HAS ABSOLUTELY NOT A REFRACTIVE ERROR/A CONSTANT ISSUE. SHE EMPHASISED THAT THESE KOL & REFRACTIVE SURGEONS HAVE A LOT OF CREDIBILITY WHICH REALLY WORRIED HER AS SHE WAS A HIGH VOLUME ACRYSOF VIVITY IMPLANTER. HER MAIN CONCERN IS WHETHER WE WILL DISCONTINUE ACRYSOF VIVITY WHEN CLAREON VIVITY IS LAUNCHED, LIKE HAS BEEN DONE WITH PANOPTIX. SHE ASKED IF POSSIBLE THE BELOW INFORMATION WOULD HELP PRIOR TO CLAREON VIVITY LAUNCH TO CLEAR UP ANY CONCERNS: ¿ OSI & MTF BENCH TEST CLAREON VIVITY VS OTHER IOLS. ¿ CONCERNS THAT FDA DATA OFTEN INCLUDES ONE TEST ONLY SIDE BY SIDE WITH ACRYSOF. ¿ ANY STUDIES COMPARING CONTRAST SENSITIVITY OF ACRYSOF VIVITY VS CLAREON VIVITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74329 CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON LABORATORIES IRELAND LTD. CCWET0 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R