BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

    MDR report key: 15898932 · Received December 1, 2022

    Report

    Report Number
    2523835-2022-00441
    Event Type
    Injury
    Date Received
    December 1, 2022
    Report Date
    April 5, 2023
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HMX
    UDI-DI
    00380654801209
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. INADVERTENT INTRASTROMAL INJECTION OF OPHTHALMIC VISCOELASTIC. J AAPOS. 2013 DEC;17(6) PAGE NUMBER 639-41. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN E.1. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF THE OPHTHALMIC VISCOSURGICAL DEVICE WAS ACCIDENTALLY INJECTED INTO THE CORNEAL STROMA; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE. PER THE DFU, VISCOAT IS TO BE INJECTED AFTER ENTERING THE ANTERIOR CHAMBER OF THE EYE. THEREFORE, THE ROOT CAUSE IS USE ERROR. THE ROOT CAUSE WAS NOT RELATED TO A MANUFACTURING ISSUE. A REVIEW OF THE SAMPLE EVALUATION REVEALED VISCOAT WAS INJECTED INTO THE EYE BEFORE ENTERING THE ANTERIOR CHAMBER. THE PRODUCT DFU PROVIDES DETAILED INSTRUCTIONS THAT VISCOAT IS TO BE INJECTED AFTER ENTERING THE ANTERIOR CHAMBER OF THE EYE. ALL CANNULA ASSEMBLIES MANUFACTURED ON THE ACAM ARE 100% INSPECTED FOR FOREIGN MATERIAL BY VISION DETECTION SYSTEM AND 100% FUNCTIONALLY TESTED FOR AIR FLOW DURING THE AUTOMATED ASSEMBLY PROCESS. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE ARTICLE REVEALED THAT WHILE TREATING A PATIENT BEFORE ENTERING THE ANTERIOR CHAMBER, OPHTHALMIC VISCOSURGICAL DEVICE WAS ACCIDENTALLY INJECTED INTO THE CORNEAL STROMA, LEAVING A 4MM OPACITY SUPERONASAL WITHIN 4 MM OF THE CENTRAL CORNEA, ON THE FIRST POSTOPERATIVE DAY VISION IMPROVED AND THERE WAS MILD SUPERIOR CORNEAL EDEMA, BY WEEKS AFTER SURGERY THE VISUAL ACUITY IMPROVED. THE CANNULA USED TO INJECT VISCOELASTIC MAY HAD CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER INFORMATION EXPECTED DUE TO UNLIKELIHOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615029 ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC CANNULA, OPHTHALMIC HMX ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU 00380654801209

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Other