BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIOLI INJECTOR

    MDR report key: 19712969 · Received July 9, 2024

    Report

    Report Number
    MW5157139
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 2, 2024
    Manufacturer
    AST PRODUCTS, INC.
    Product Code
    MSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LENS WAS FOLDED AND INSERTED INTO THE ANTERIOR CHAMBER. AT THIS POINT IN THE PROCEDURE, SMALL FINE DEPOSITS WERE NOTED TO BE SURROUNDING THE LENS EMBEDDED IN THE OCUCOAT. OCUCOAT WAS INJECTED OVER THE ICL. GIVEN THE FINE PARTICULATE MATTER, THE DECISION WAS MADE TO EXPLANT THE FIRST LENS. THIS WAS DONE USING INTRAOCULAR FORCEPS. THE ANTERIOR CHAMBER WAS WASHED OUT WITH BALANCED SALT SOLUTION USING IRRIGATION AND ASPIRATION. OCUCOAT WAS RE-INSERTED INTO THE EYE AND THE BACK UP LENS WAS INSERTED (SN (B)(6)), USING A NEW LIOLI INJECTOR. AGAIN FINE PARTICULATE DEPOSITS WERE NOTED IN THE OCUCOAT SURROUNDING THE LENS AFTER INSERTION WITH THE LIOLI INJECTOR. MORE OCUCOAT WAS INJECTED OVER THE LENS. THE FOOTPLATES WERE MANIPULATED AND POSITIONED IN THE SULCUS. THE LENS WAS THEN ROTATED INTO POSITION. THE PARTICULATE MATTER AFTER INSERTION OF THE SECOND LENS APPEARED TO BE ALMOST TOTALLY REMOVED WITH COPIOUS IRRIGATION AND ASPIRATION. PATIENT WHO RECENTLY UNDERWENT AN EYE PROCEDURE AT OUTPATIENT CENTER FOR SEVERE MYOPIC ASTIGMATISM. THE PATIENT WAS TO HAVE BILATERAL IMPLANTED CONTACT LENS FOR VISION CORRECTION. INITIALLY, THERE WERE CONCERNS DURING THE PROCEDURE REGARDING THE LENS POSSIBLY CONTAINING PARTICULATES, THEREFORE, ANOTHER LENS WAS REQUESTED AND USED DURING THE PROCEDURE. IT WAS LATER DETERMINED THAT THE ISSUE LAY WITH THE INJECTOR USED. SUBSEQUENTLY, THE SURGEON RECOMMENDED PERFORMING THE PROCEDURE ON THE PATIENT'S OTHER EYE DURING A SEPARATE ENCOUNTER DUE TO THESE ISSUES WITH THE FIRST EYE. REPORTED THAT THE INJECTORS ARE ORDERED THROUGH STAAR SURGICAL. STAAR SURGICAL, LAKE FOREST, CA 92630 US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348197 LIOLI INJECTOR FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS AST PRODUCTS, INC. FCK2002

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention IMPLANTABLE CONTACT LENS| OCUCOAT