BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 19011879 · Received April 1, 2024

    Report

    Report Number
    1119421-2024-00592
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 1, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE SURGEON INDICATED THE IOL PROBABLY POSITIONED ITSELF DIFFERENTLY DURING THE POSTOPERATIVE WOUND HEALING PROCESS THAN THE CALCULATION FORMULAS ASSUMED. THE POSTOPERATIVE TOPOGRAPHY ALSO SHOWS SLIGHT CHANGES COMPARED TO THE PREOPERATIVE STATUS. AN IOL EXCHANGE IS NOT PLANNED AT THE MOMENT; THEY WANTED TO IMPLANT AN ADDON IOL, BUT THE PATIENT REJECTED THAT OPTION. PATIENT TRIED WEARING IT WITH -1.0, AND NOW SEES 0.8 ON THE EYE. THE PATIENT WOULD CONTACT SITE WHEN THEY DECIDE HOW TO PROCEED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. FILE WILL BE REOPENED WHEN NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    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 (DFT215) 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED RESIDUAL REFRACTION. ON SURGEON OPINION EVENT CAUSED DUE TO IOL PROBABLY POSITIONED ITSELF DIFFERENTLY DURING THE POSTOPERATIVE WOUND HEALING PROCESS. PATIENT REJECTED IOL EXCHANGE AND WANTED THE SECOND OPINION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518277 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15663403

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female