BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LASER

    MDR report key: 20264924 · Received September 20, 2024

    Report

    Report Number
    2028159-2024-01422
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    UDI-DI
    00380657505975
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN APPLICATION DEFECT IN THE SERVICING DATABASE WAS INTERNALLY IDENTIFIED, WHICH RESULTED IN A VOLUNTARY 5-YEAR RETROSPECTIVE REVIEW (2019-2024) OF DATABASE DATA; THIS REPORT REPRESENTS A REPORTABLE EVENT IDENTIFIED DURING THE COURSE OF THIS REVIEW 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 UNABLE TO CONFIRM NOR REPLICATE THE REPORTED EVENT. 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 NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. 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. THE SYSTEM WAS FOUND TO HAVE NO PROBLEM. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC LASER HAS LOW PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223193 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657505975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown