BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 21404348 · Received February 18, 2025

    Report

    Report Number
    2523835-2025-00135
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 22, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    KYG
    UDI-DI
    00380657515103
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.11. UPON FURTHER REVIEW, THE FDA DEVICE EVENT CODE HAS SUCTION FAILURE - A141303 BEEN RETRACTED FROM THE FILE, AS THIS EVENT DOES NOT PERTAIN TO THE OPHTHALMIC SYSTEM. ONE OPENED POLYMER IRRIGATION AND ASPIRATION TIP WAS RETURNED FOR THE REPORT OF AN ASPIRATION ISSUE DUE TO AN OBSTRUCTION. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND TO BE NON-CONFORMING WITH THREADS OBSERVED TO BE BROKEN. THE HUB RIBS WERE TWISTED IN A SPIRALING MOTION. NO FOREIGN MATERIAL OR OBSTRUCTION WAS OBSERVED IN TIP PORT HOLE; HOWEVER, PROCEDURAL RESIDUE WAS OBSERVED AT PORT HOLE AND ON CANNULA. A FUNCTIONAL WATER FLOW CHECK COULD NOT BE PERFORMED DUE TO THE VISUAL DAMAGE, OCCLUSION WATER FLOW CHECK COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED NON-CONFORMING SAMPLE WAS RECEIVED OPENED. HOW AND WHEN THE IRRIGATION AND ASPIRATION TIP BECAME DAMAGED AND BROKEN CANNOT BE DETERMINED FROM THIS EVALUATION. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED SAMPLE; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED OCCLUSION ISSUE AS DESCRIBED BY THE CUSTOMER. THE MOST LIKELY ROOT CAUSE FOR THE DAMAGED AND BROKEN TIP IS HANDLING WHEN PLACING THE TIP ONTO THE HANDPIECE. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL IRRIGATION AND ASPIRATION TIPS ARE 100% VISUALLY INSPECTED PRIOR TO BEING RELEASED FROM THE MANUFACTURING FACILITY. 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 PHYSICIAN REPORTED THAT DURING CATARACT SURGERY ASPIRATION FAILURE OCCURRED DUE TO OBSTRUCTION IN AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP. THE SURGERY WAS COMPLETED WITH ALTERNATE TIP ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572910 DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS DEVICE, IRRIGATION, OCULAR SURGERY KYG ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 16N4R0 00380657515103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown