BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 24883447 · Received April 15, 2026

    Report

    Report Number
    2028159-2026-00495
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657511501
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS B.5, H.6 AND H.11. UPON FURTHER REVIEW OF ADDITIONAL INFORMATION, THE FDA PRODUCT CODE ¿A141303 - SUCTION FAILURE¿ HAS BEEN RETRACTED FROM THE REPORT AND WAS 'A1413 - SUCTION PROBLEM' ADDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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

    ADDITIONAL INFORMATION RECEIVED THAT PRIOR VITRECTOMY SURGERY; THE COMBINED OPHTHALMIC CASSETTE WAS TESTED ON THE OPHTHALMIC SYSTEM AND PASSED WITHOUT ISSUE. HOWEVER, UPON INITIATING USE OF THE OPHTHALMIC VITRECTOMY HANDPIECE, BOTH THE ASPIRATION AND CUTTING FUNCTIONS FAILED FOR SEVERAL TIMES. WHEN ALTERNATIVE VITREOUS PACK CASSETTE WAS TESTED IT PASSED BUT FAILED DURING SURGERY. AFTER FOLLOWING THE VACUUM PARAMETER INSTRUCTIONS PROVIDED BY ENGINEER, THE ISSUE STILL PERSISTED. ON REUSING THE ORIGINAL COMBINED CASSETTE HANDPIECE AND FOLLOWED THE VACUUM PARAMETER INSTRUCTIONS PROVIDED. THIS TIME, THE OPHTHALMIC HANDPIECE FUNCTIONED PROPERLY, ALLOWING US TO BEGIN THE PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING SURGERY, PROBLEMS WITH VITREOUS ASPIRATION IN AN OPHTHALMIC SYSTEM. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. 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
    356322 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER TABLETOP NA 00380657511501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONSTELLATION SURGICAL PROCEDURE PAK.