BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 19474673 · Received June 6, 2024

    Report

    Report Number
    1119421-2024-01079
    Event Type
    Injury
    Date Received
    June 6, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652405775
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE REPORTING FACILITY INDICATED THE ISSUE AS RELATED TO A CLERICAL ERROR-WRONG LENS WAS CHOSEN. THE REPLACEMENT LENS WAS NOT PROVIDED. EACH LENS IS SUBJECTED TO A 100PERCENTAGE 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 FACILITY HAS NOT RESPONDED TO REQUESTS FOR FOLLOW-UP INFORMATION. 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 FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS WRONG POWER CHOSEN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179 CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON CCWET0 15684809 00380652405775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention