BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 15884919 · Received November 30, 2022

    Report

    Report Number
    3002037047-2022-00086
    Event Type
    Injury
    Date Received
    November 30, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P840064
    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

    NO LOT CODE OR SAMPLE PROVIDED. NO FURTHER EVALUATION OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED AS NO SAMPLE OR LOT CODE WAS PROVIDED FOR ANALYSIS. NO ACTION IS WARRANTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966538 VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

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