BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 14770620 · Received June 22, 2022

    Report

    Report Number
    1119421-2022-01338
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 23, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    UDI-DI
    00380652395243
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU (INSTRUCTIONS FOR USE). A NON-QUALIFIED VISCOELASTIC WAS USED IN THE DEVICE. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE COMPANY IQ IOL WITH THE COMPANY PRELOADED DELIVERY SYSTEM, AN COMPANY QUALIFIED OPHTHALMIC VISCOELASTIC DEVICE (OVD) SHOULD BE USED. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE DEVICE PREPARATION AND IMPLANTATION STEPS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL) WAS REPORTED, ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON EVALUATION OF THE EYE POST-OPERATIVELY, IT WAS NOTED THAT THE LENS HAS SHIFTED FROM THE BAG DUE TO FAULTY HAPTIC AND THERE WAS NO LONGER IN POSITION. ONE MONTH OF INITIAL IMPLANT THE IOL WAS REPOSITIONED SUCCESSFULLY. THE PHYSICIAN MENTIONED THAT, THE ISSUE IS WITH THE INJECTOR, NOT THE LENS ITSELF. THE LENS COME OUT TWISTED FROM THE INJECTOR ALMOST ALL THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536270 ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON ACU0T0 15301093 00380652395243

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention HEALON VISCOELASTIC