BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B

    MDR report key: 15884921 · Received November 30, 2022

    Report

    Report Number
    1119421-2022-02522
    Event Type
    Injury
    Date Received
    November 30, 2022
    Report Date
    February 27, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    UDI-DI
    00380659777585
    PMA / PMN Number
    K001157
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. MS HICKMAN, L WERNER, N MAMALIS, E SUNG, D GOLDSTEIN, DT VROMAN AND SK PANDEY. INTRAOPERATIVE EXPLANATION OF TWO SINGLE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES DUE TO SURFACE DEPOSITS. EYE (2006) 20, 1054¿1060. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.10. THE PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THIS COMPLAINT WAS OPENED FROM A 2005 LITERATURE REPORT: INTRAOPERATIVE EXPLANTATION OF TWO SINGLE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES DUE TO SURFACE DEPOSITS. REVIEW OF THE PROVIDED PHOTOS APPEAR TO SHOW DEPOSITS ON THE SURFACE OF THE LENSES. THESE DEPOSITS COVER A LARGE SURFACE AREA OF EACH LENS AND HAVE THE APPEARANCE OF DRIED OVD OR OTHER SOLUTION. THE ¿DEPOSITS¿ DO NOT APPEAR TO BE LENS DAMAGE OR RELATED TO THE CARTRIDGE. THE REPORT INDICATED THAT SURFACE ANALYSES PERFORMED ON THE MATERIAL OBSERVED INTRAOPERATIVELY BY THE SURGEONS ONLY DEMONSTRATED THE PRESENCE OF ELEMENTS THAT MAY BE NORMAL COMPONENTS OF DIFFERENT OVD PREPARATIONS. THE REPORT FURTHER INDICATED THAT ¿HYPOTHETICALLY, ALTHOUGH THE ANALYSES PERFORMED WERE NOT CONCLUSIVE, OVD PRECIPITATION MIGHT HAVE OCCURRED IN THE CASES REPORTED HERE UNDER DIFFERENT CIRCUMSTANCES, AFTER LENS LOADING INTO THE INJECTOR, OR IMMEDIATELY AFTER INJECTION OF THE LENS INTO THE EYE¿. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    IN A JOURNAL ARTICLE, NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN NOTED THAT IT WAS DIFFICULT INJECTING THE LENS INTO THE EYE WITH A CRUNCHING SOUND. UPON INSERTION, A WHITE, GRANULAR MATERIAL WAS NOTED IMMEDIATELY ON THE LENS AND IN THE ANTERIOR CHAMBER. ATTEMPTS TO REMOVE THIS MATERIAL BY IRRIGATION AND ASPIRATION WERE ONLY PARTIALLY SUCCESSFUL. THE LENS WAS THEN CUT IN HALF WITH SCISSORS AND REMOVED. VIGOROUS IRRIGATION AND ASPIRATION WAS USED TO REMOVE THE REMAINING OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND THE WHITE, GRANULAR MATERIAL FROM THE CAPSULAR BAG. SOME OF THIS MATERIAL WAS NOTED IN THE CLEAR CORNEAL WOUND, WHICH COULD NOT BE REMOVED. ANOTHER SAME MODEL LENS WAS THEN INJECTED INTO THE BAG. POSTOPERATIVELY, THE PATIENT INITIALLY DEVELOPED CORNEAL EDEMA AT 1 WEEK. AT 1 MONTH POSTOPERATIVELY, THE LAST TIME THE PATIENT WAS SEEN, THE EYE WAS QUIET, THE CORNEAL EDEMA HAD RESOLVED. IT WAS REPORTED THAT OPHTHALMIC VISCO SURGICAL PRECIPITATION MIGHT HAVE OCCURRED IN THE CASE REPORTED HERE UNDER DIFFERENT CIRCUMSTANCES, AFTER LENS LOADING INTO THE INJECTOR, OR IMMEDIATELY AFTER INJECTION OF THE LENS INTO THE EYE. RESIDUES FROM CARTRIDGES COATING ARE ALSO A POSSIBILITY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR 1ST REPORT OUT OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966540 MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA ASKU 00380659777585

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| O ACRYSOF SINGLEPIECE IOL| MONARCH II IOL DELIVERY SYSTEM, INJECTOR| VANNAS SCISSORS| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE