BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 20786501 · Received November 26, 2024

    Report

    Report Number
    2028159-2024-01842
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 15, 2025
    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
    PO
    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).

    Additional Manufacturer Narrative · 0

    A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. DOCUMENT, CORRECT, AND TREND (DCT) 668869 WAS OPENED FOR OOT ¿ Y45-0324 ANALYZER, ELECTRICAL SAFETY.W/LOGGER. THE COMPLAINT WAS DETERMINED TO NOT BE RELEVANT TO THIS INVESTIGATION. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION WITH THE SAME EVENT CODE. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. A SERVICE RECORD RELEVANT TO THE REPORTED COMPLAINT WAS FOUND. SERVICE RECORD (SR) (B)(6) WAS OPENED ON OCTOBER 29, 2024 TO ADDRESS THE REPORTED EVENT. PER THE SR, AN ALCON REPRESENTATIVE (AR) PERFORMED AN ON-SITE ASSESSMENT AND REPLICATED THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE AR REPLACED THE NONCONFORMING ASSY, LAMP, XENON OSRAM FLD SVC (P/N: 212-3338-501), THEN FOUND THE SYSTEM TO MEET ALCON SPECIFICATIONS PER SERVICE TEST PROCEDURE (STP). ON OCTOBER 29, 2024 THE CUSTOMER REPORTED THAT THEIR CONSTELLATION VISION SYSTEM XT (PART NUMBER (P/N) 8065751150, SERIAL NUMBER (S/N) (B)(6)) LIGHTING MODULE WAS NOT WORKING. PER THE SR, AN AR PERFORMED AN ON-SITE ASSESSMENT AND REPLICATED THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE AR REPLACED THE NONCONFORMING XENON LAMP, THEN FOUND THE SYSTEM TO MEET ALCON SPECIFICATIONS PER STP. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO A NONCONFORMING ASSY, LAMP, XENON OSRAM FLD SVC (P/N: 212-3338-501). AS A CORRECTION, THE MANUFACTURER REPRESENTATIVE PERFORMED AN ON-SITE ASSESSMENT OF THE EQUIPMENT AND REPLACED A NONCONFORMING XENON LAMP. ACTIONS TAKEN PER THE SR RESOLVED THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REVIEWED AND BASED ON A LOW OCCURRENCE RATE, IT IS DETERMINED THAT NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE RISK MANAGEMENT REPORT (RMR) 926-2350-001 REV. DG WAS REVIEWED, AND THE HAZARDS/HARMS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED. SIMILAR INCIDENT/EVENT DATA WAS COLLECTED FOR THE ASSOCIATED REPORTED EVENTS. QUALITY ASSURANCE WILL CONTINUE TO PERFORM PERIODIC MONITORING FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION AS APPROPRIATE. REFER TO THE ATTACHED FILE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN OPHTHALMIC SYSTEM HAD LIGHTING MODULE NOT WORKING. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827088 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER TABLETOP NA 00380657511501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown