BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION IOL

    MDR report key: 13693698 · Received March 8, 2022

    Report

    Report Number
    1119421-2022-00422
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    September 23, 2021
    Report Date
    March 8, 2022
    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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GREAT PHOTOPHOBIA OF LIGHT THAT MAKES IT IMPOSSIBLE TO SEE DURING THE DAY (EXCEPT IN THE DARK), AN ENORMOUS GLARE AT ANY LIGHT SOURCE (SCREEN, MOBILE, COMPUTER, TV AND MULTIPLE FLASHES IF IT GOES OUT AT NIGHT TO ANY LIGHT SOURCE. IT MAKES IT IMPOSSIBLE FOR HIM TO LEAD A NORMAL LIFE, DRIVING, WATCHING TV. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336656 ACRYSOF IQ VIVITY EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other