BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 19200306 · Received April 29, 2024

    Report

    Report Number
    1119421-2024-00809
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    March 26, 2024
    Report Date
    July 3, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. 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) # (P040020). 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 WITH A NON-QUALIFIED VISCOELASTIC. AN UNSPECIFIED HANDPIECE WAS INDICATED. IT IS UNKNOWN, IF A QUALIFIED HANDPIECE WAS USED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE. TO FOLLOW THE INSTRUCTIONS FOR USE (IFU). THE VISCOELASTIC INDICATED, IS NOT QUALIFIED FOR THE LENS/MONARCH COMBINATION USED. THE IFU INSTRUCTS THAT A 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 ACCOUNT INDICATED, THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. DUE DILIGENCE, HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE ACCOUNT INDICATED, THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. PLEASE BE AWARE, THAT THERE IS CURRENTLY A BAN ON THE EXPORT OF MEDICAL DEVICES FROM THE RUSSIAN FEDERATION. THE FILE WILL BE REOPENED, IF THE SAMPLE BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    OTHER HEALTH CARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC OF THE LENS WAS TORN OFF DURING IMPLANTATION INTO THE ANTERIOR CHAMBER. CARTRIDGE WERE USED. THE LENS REMAINED IN THE PATIENT'S EYE. A WEEK LATER, THE PATIENT HAD TO REPLACE THE LENS WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979344 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15604276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention COGEVISK OVD| MONARCH III CARTRIDGE D| MONARCH IOL INJECTOR, UNSPECIFIED