BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 13559617 · Received February 18, 2022

    Report

    Report Number
    1119421-2022-00313
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 1119421-2022-00336. NO ADDITIONAL REPORTS WILL BE FILED ON THIS REPORT NUMBER.¿ ANY ADDITIONAL INFORMATION THAT IS RECEIVED WILL BE REPORTED ON MANUFACTURER REPORT NUMBER 1119421-2022-00336. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2022-06307.

    Description of Event or Problem · 0

    A NURSE REPORTED DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PLUNGER WAS HARD TO PUSH AND SUDDENLY IT COME LOOSE AND MADE THE IOL TO GET INTO THE EYE AS A PROJECTILE, RESULTING IN AN CAPSULAR BREAK. THE PATIENT WAS LEFT WITHOUT ANY LEN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REQUESTED AND RECEIVED WHICH STATES THAT THERE WAS ALSO DAMAGE TO THE CORNEAL ENDOTHELIUM, ALTHOUGH UNCLEAR WHETHER DURING IMPLANTATION OR THE EXPLANTATION OF THE IOL. A SECONDARY IMPLANTATION OF AN IRIS FIXED IOL IS PLANNED, POSSIBLY ALSO A CORNEAL ENDOTHELIUM TRANSPLANTATION MAY BE NEEDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED WHICH STATES THAT THIS FILE IS A DUPLICATE OF PR 1934269 AND THEREFORE HAS TO BE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867183 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15273123
    468893 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15273123

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE