BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 24516250 · Received March 5, 2026

    Report

    Report Number
    2523835-2026-00221
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    KYG
    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

    CORRECTED INFORMATION WAS PROVIDED IN SECTION H.6. THE FDA PRODUCT CODE WAS UPDATED FROM A141303 TO A1409 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF AN ASPIRATION ISSUE; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. BASED ON THE EVALUATION OF THE INFORMATION RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. ALL I/A TIPS ARE 100% VISUALLY INSPECTED PRIOR TO BEING RELEASED FROM THE MANUFACTURING FACILITY. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL MANUFACTURER PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT OPHTHALMIC TIP WAS UNABLE TO ASPIRATE WHEN THE IRRIGATION AND ASPIRATION WAS USED DURING CATARACT SURGERY. THE DETAILS OF THE PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575913 DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS DEVICE, IRRIGATION, OCULAR SURGERY KYG ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUSTOM-PAK SURGICAL PROCEDURE PACK.