BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 22529772 · Received July 17, 2025

    Report

    Report Number
    1119421-2025-01956
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 10, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422895
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 DFT315-615 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE LENS WAS RETURNED POSITIONED INCORRECTLY IN THE LENS CASE INSIDE THE LENS CARTON. VISCOELASTIC WAS DRIED ON THE LENS. ONE HAPTIC WAS BENT IN THE GUSSET AREA. THE OTHER HAPTIC WAS BROKEN IN THE DISTAL AREA AND HAS CRACKS IN THE POSTERIOR OPTIC OR HAPTIC JUNCTION. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED CARTRIDGE AND HANDPIECE INFORMATION WAS NOT PROVIDED. A VISCOELASTIC WAS INDICATED THAT IS QUALIFIED FOR USE WHEN USED WITH A QUALIFIED COMPANY CARTRIDGE AND HANDPIECES. THE REPORTED DAMAGED HAPTIC WAS OBSERVED. A BENT HAPTIC AND A BROKEN HAPTIC WERE OBSERVED. ALL LENSES ARE 100PERCENTAGE INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET COMPANY RELEASE CRITERIA. BASED ON OUR OBSERVATION, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. FILE WILL BE REOPENED IF NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE LENS HAPTIC WAS DAMAGED. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED WITH THE BACK UP LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615868 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15756260 00380652422895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DUOVISC OVD.