BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 23617948 · Received November 21, 2025

    Report

    Report Number
    1644019-2025-04943
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524372
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE LEAKED BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER PRODUCT WAS REPLACED. THERE WAS NO PATIENT CONTACT. SOUTH AFRICA FINAL REPORT: 2025-89548-01, FILE ID 2939362, QS FILE ID 2946754. NAMES OF ANY OTHER REGULATORY AUTHORITIES TO WHICH THESE EVENTS HAVE BEEN REPORTED: U.S. FOOD AND DRUG ADMINISTRATION. DATE OF THE REPORTS: 10/23/2025 06:05 AM. SERIAL NUMBER/LOT NUMBER: 17F52Y. BATCH NUMBER: NA. SOFTWARE VERSION: NA. CURRENT KNOWN LOCATION OF THE MEDICAL DEVICE INVOLVED IN THE EVENT: MANUFACTURER ANY HCR / LICENSED MANUFACTURER, OR LICENSED DISTRIBUTOR COMMENTS: NA. ANY OTHER COUNTRIES IN WHICH THE MEDICAL DEVICE IS KNOWN TO BE ON SALE OR SUPPLIED: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GRAND TOTAL, HONG KONG, HUNGARY, ICELAND, INDIA, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN/AFGHANISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, UNITED KINGDOM, UKRAINE, URUGUAY, UNITED STATES, UZBEKISTAN, VIETNAM AND ZAMBIA. TABLE 1: SALES DATA: SOUTH AFRICA SALES: 6968. WORLDWIDE (EXCLUDING SOUTH AFRICA) SALES: 1997200. SALES SEARCH CRITERIA: CONSTELLATION SURGICAL PROCEDURE PACK FAMILY FROM (B)(6) 2024. TABLE 2A: SIMILAR EVENTS DATA (CONSTELLATION SURGICAL PROCEDURE PACK, CASSETTE LEAKAGE -REPORTABLE MALFUNCTION. SOUTH AFRICA. SIMILAR EVENTS: 2. WORLDWIDE (EXCLUDING SOUTH AFRICA). SIMILAR EVENTS: 129. SIMILAR EVENTS SEARCH CRITERIA: (CONSTELLATION SURGICAL PROCEDURE PACK, CASSETTE LEAKAGE -REPORTABLE MALFUNCTION. TABLE 2B: RATE (PER 1000). SOUTH AFRICA RATE: (B)(4). WORLDWIDE (EXCLUDING SOUTH AFRICA) RATE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303701 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17F52Y 00380657524372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown