BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 16910296 · Received May 11, 2023

    Report

    Report Number
    1119421-2023-00876
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    September 1, 2022
    Report Date
    August 8, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652424660
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACCOUNT INDICATED THE USE OF AN UNSPECIFIED CARTRIDGE AND HANDPIECE. A VISCOELASTIC WAS INDICATED WHICH IN NOT QUALIFIED FOR USE WITH THIS LENS WITH ANY QUALIFIED LENS/CARTRIDGE COMBINATION. 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 21.5 DIOPTER, (1.5 EXTENDED DEPTH OF FOCUS) LENS WAS REPLACED WITH A NON-COMPANY, 21.0 DIOPTER, MONOFOCAL LENS MODEL. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE CLINICAL REASON FOR THE EXCHANGE WAS, "POSSIBLY COMBINATION OF HOAS AND NEUROADAPTATION ISSUES." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. FILE WILL BE REOPENED WHEN NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POSSIBLY COMBINATION OF HOAS (HIGHER ORDER ABERRATIONS) AND NEUROADAPTATION ISSUES. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189409 ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DAT015 15244375 00380652424660

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention ANIKAVISC.| ORA SYSTEM.| UNSPECIFIED HANDPIECE.