BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXOR OPHTHALMIC MICROSCOPES

    MDR report key: 19930918 · Received August 7, 2024

    Report

    Report Number
    2028159-2024-01148
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 10, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HRM
    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

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS D.9, H.3 H.6 AND H.11. THE COMPANY REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT. THE STAND WAS REPLACED TO ADDRESS THE ISSUE. THE STAND WAS RETURNED FOR TESTING ON THIS INVESTIGATION. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. THE STAND WAS RECEIVED FOR THIS INVESTIGATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED NO OBVIOUS NONCONFORMITY. DURING FURTHER INSPECTIONS ON THE REPORTED COMPLAINT, IT WAS DETERMINED THAT TWO MOUNTING HOLES EXHIBIT A DAMAGED THREAD. THE REPORTED COMPLAINT IS CONFIRMED. HOW OR WHY THE THREADS BECAME DAMAGED CANNOT BE CONCLUSIVELY DETERMINED. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE NONCONFORMING STAND. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT, AN OPHTHALMIC MICROSCOPE SCREW DID NOT FIT DURING INSPECTION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560505 LUXOR OPHTHALMIC MICROSCOPES MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC HRM ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LX3 16NYE5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown