BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION IOL

    MDR report key: 16743392 · Received April 14, 2023

    Report

    Report Number
    1119421-2023-00670
    Event Type
    Injury
    Date Received
    April 14, 2023
    Report Date
    April 14, 2023
    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
    CA
    Reporter Occupation
    PHYSICIAN
    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 PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH A 6 MONTH HISTORY OF DIFFICULTY WITH TROUBLE WITH DRIVING AT NIGHT WITH HALOS, GLARE AND READING FINE PRINT. THE PATIENT REFRACTION IS -0.50+0.25X112 AND CLINICAL EXAM LOOKS NORMAL. THE PATIENT IS EXTREMELY UNHAPPY. INITIALLY THE PATIENT SAID IT WAS JUST BLURRY. NOW, PATIENT SAYS THAT HER VISION IS FINE DURING THE DAYTIME BUT SHE DOESN¿T FEEL SAFE DRIVING AT NIGHT AND CAN¿T JUDGE THE DISTANCE A CAR IS IN FRONT OF HER. THE PATIENT¿S HUSBAND STATES, THE SAME THINGS SHE WAS COMPLAINING ABOUT BEFORE SURGERY BUT SHE IS ADAMANT THAT THIS IS WORSE THAN BEFORE EVEN THOUGH HER VISION IS BETTER. RIGHT AFTER SURGERY OF THE SECOND EYE SHE MENTIONED SHE HAD DIPLOPIA ALONG WITH GENERAL BLUR AND I FOUND SHE HAD 1-2 PRISM D OF RIGHT HYPER. HENCE SENT HER TO THE OCULARISTS WHO FELT SHE HAD A LONGSTANDING 1-2 D HYPERPHORIA AND THEY PUT A FRESNEL ON CLEAR LENS FOR HER TO TRY FOR A WHILE BUT THIS MADE NO DIFFERENCE. THE FACT THAT SHE IS GOOD DURING THE DAY BUT STRUGGLES AT NIGHT SOUNDS LIKE A CONTRAST SENSITIVITY ISSUE TO THE SURGEON BUT SURGEON THOUGHT THE BIG CLAIM TO FAME FOR THE COMPANY LENS WAS NO IMPACT ON CONTRAST SENSITIVITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387271 ACRYSOF IQ VIVITY EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other