BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 18765512 · Received February 23, 2024

    Report

    Report Number
    1119421-2024-00335
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A QUALIFIED HANDPIECE WAS INDICATED. THE CARTRIDGE AND VISCOELASTIC USED WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. THE SPECIFIC ISSUE WAS NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS: COMPANY FOLDABLE INTRAOCULAR LENS (IOLS) ARE QUALIFIED FOR USE WITH COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE REPORTER HAS NOT RESPONDED TO FOLLOW UP REQUESTS. FILE WILL BE REOPENED IF NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 (FILL IN APPLICABLE PRODUCT MODEL INFORMATION T3-T6 MODELS) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014).¿ THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS WAS REMOVED DURING INITIAL PROCEDURE.

    Description of Event or Problem · 0

    OTHER HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY LENS. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129798 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15335341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DUOVISC| MONARCH III INJECTOR