BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 16887379 · Received May 8, 2023

    Report

    Report Number
    1119421-2023-00854
    Event Type
    Injury
    Date Received
    May 8, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652424578
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE 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 PROVIDED IN B.2., B.5., B.6., D.10., H.3., H ,6. AND H,10. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION WAS PROVIDED THAT THE LENS REMAINS IMPLANTED. THE EXPLANT SURGERY WAS CANCELED FOR THIS EYE. THE REPORTING FACILITY HAS NOT PROVIDED ANY FURTHER INFORMATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION/DIFFICULTY WITH VISION, CANNOT READ WELL AND HAVING TROUBLE WITH INTERMEDIATE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH MONOFOCAL LENS. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WAS ONLY CORRECTABLE TO DISTANCE 20/30, INTERMEDIATE 20/40. READING JIO. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS TWO OF TWO.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE EXPLANT SURGERY WAS CANCELLED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877697 ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DAT015 15232437 00380652424578

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O MONARCH III INJECTOR| MONARCH III , CARTRIDGE D| PROVISC| REPLACEMENT LENS: UNSPECIFIED TORIC MONOFOCAL LENS