BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 21827446 · Received April 11, 2025

    Report

    Report Number
    1119421-2025-01012
    Event Type
    Injury
    Date Received
    April 11, 2025
    Report Date
    May 26, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6. CORRECTION: ON INITIAL MDR THE FDA HEALTH IMPACT CODE F19 WAS AN ERROR. IT SHOULD HAVE BEEN F24 ON THE ORIGINAL MDR. THE FDA PATIENT EVENT CODES E0838, E0815, E0112, E083903 WAS REMOVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4) H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, ON (B)(6) 2024 AND (B)(6) 2024 PATIENT HAD INTRAOCULAR LENSES FROM COMPANY INSERTED IN BOTH EYES. AT THE FOLLOW UP APPOINTMENTS, IT TURNED OUT THAT THE LENSES INSERTED WERE TORIC INTRA OCULAR LENS (IOLS), CONTRARY TO THE SURGEONS' INSTRUCTIONS. ACCORDING TO SURGEON MEASUREMENTS, NO CORRECTION OF THE CORNEAL CURVATURE WAS NECESSARY. AS A RESULT, PATIENT SUFFERED FROM SEVERE VISUAL COMPLAINTS. IN (B)(6) 2024, HIS COMPANY DOCTOR DETERMINED THAT THE VISUAL PERFORMANCE ON BOTH SIDES WAS ALSO INSUFFICIENT IN THE INTERMEDIATE RANGE. THE VISUAL PROBLEMS MADE FURTHER LASER TREATMENT NECESSARY IN (B)(6) 2025. ANOTHER LASER TREATMENT IS PLANNED FOR (B)(6) 2025. HE STILL SUFFERS FROM DOUBLE VISION, BLURRED VISION, DRY EYES AND RAPID FATIGUE WITH FOCUSED VISION. THE CONSEQUENCES FOR HIM ARE NOT ONLY HEALTH RESTRICTIONS, WHICH CONTINUE TO THIS DAY AND ARE ONLY SLOWLY IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079054 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15670226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention