BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 21883826 · Received April 22, 2025

    Report

    Report Number
    1119421-2025-01138
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 14, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422918
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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 ACCOUNT INDICATED THE USE OF A QUALIFIED ASSOCIATED CARTRIDGE AND HANDPIECE WITH A NON-QUALIFIED VISCOELASTIC. THE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE TO FOLLOW THE (FAILURE TO FOLLOW THE INSTRUCTIONS) IFU. THE VISCOELASTIC INDICATED IS NOT QUALIFIED FOR THE LENS/MONARCH COMBINATION USED. 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 IFU INSTRUCTS: USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. THE ACCOUNT INDICATED THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. FILE WILL BE REOPENED IF NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED WHILE INSERTING IT INTO THE INSERTER. THE IOL WAS NOT IMPLANTED INTO THE EYE. THERE WAS NO CONTACT OF THE PATIENT WITH THE PRODUCT. THE SURGERY COMPLETED WITH SAME MODEL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628494 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15765875 00380652422918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| HYPROMEL 2,4% 2 ML LOT: XA050B.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.