BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION IOL

    MDR report key: 17458871 · Received August 4, 2023

    Report

    Report Number
    1119421-2023-01395
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    July 7, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652421157
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    THE PROVIDED PHOTOS WERE CLINICALLY EVALUATED. GIVEN THE LIMITATIONS OF TWO-DIMENSIONAL AND BLURRED IMAGES, THE PHOTOS DISPLAY VARYING DEGREES OF ANTERIOR SEGMENT INFLAMMATION, RANGING FROM QUIET/MILD TO MODERATE. THERE IS NO EVIDENCE OF SEVERE ANTERIOR SEGMENT INFLAMMATION. WHILE THE ANOMALY OBSERVED WITHIN THE PUPIL OF THE FIRST PHOTOGRAPH MIGHT REPRESENT THE REPORTED EXUDATIVE MEMBRANE, THE ANALYSIS OF THESE THREE PHOTOGRAPHS CANNOT DEFINITIVELY CONFIRM THIS FINDING. ADDITIONALLY, THE REPORTED HAZY FUNDUS GLOW CANNOT BE CONFIRMED, AS A FUNDUS RED REFLEX WAS NOT APPARENT IN ANY OF THE THREE PHOTOGRAPHS EXAMINED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. ALL INTRAOCULAR LENS (IOLS) ARE TERMINALLY STERILIZED WITH 100% ETHYLENE OXIDE STERILIZATION. COMPANY USES AN OVERKILL STERILIZATION APPROACH, WHICH GREATLY EXCEEDS THE MINIMUM REQUIREMENTS FOR STERILITY. CRITICAL PARAMETERS FOR STERILIZATION CYCLES ARE RECORDED AND RETAINED FOR EVERY STERILIZATION LOAD TO DEMONSTRATE THAT THE ACCEPTANCE CRITERIA FOR THE STERILIZATION PROCESS ARE MET. TO ENHANCE THE PHOTOGRAPHIC ANALYSIS OF THIS REPORTED EVENT, IT WOULD BE BENEFICIAL TO RECEIVE STEREOSCOPIC IMAGES, ADDITIONAL PHOTOS TAKEN FROM VARIOUS ANGLES, IMAGES CAPTURING VARIOUS DEPTHS, AND/OR VIDEO DOCUMENTATION FOR EVALUATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT FOLLOWING DAY OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE INFLAMMATORY RESPONSE, EXUDATIVE MEMBRANE AROUND IOL, FUNDUS GLOW SEE HAZY. SECOND FOLLOW-UP ON (B)(6)-SITUATION WAS WORSEN, FUNDUS NOT SEEN, SEVERE EXUDATION AROUND IOL IN SPITE OF STEROIDS AND CYCLOPLEGICS. THE PATIENT HAD CONJUNCTIVAL INFLAMMATION, AQUEOUS CELL +2, AQUEOUS FIBRIN-PRESENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951478 ACRYSOF IQ VIVITY EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT015 15287773 00380652421157

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention