BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LASER

    MDR report key: 16465631 · Received March 2, 2023

    Report

    Report Number
    2028159-2023-00269
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Report Date
    May 2, 2023
    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
    BR
    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

    THE COMPANY REPRESENTATIVE WAS UNABLE TO CONFIRM OR REPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET SPECIFICATIONS. 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. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. 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 CUSTOMER REPORTED THAT AN OPHTHALMIC LASER CONSOLE EXHIBITED LOW LASER ENERGY AND ONE OF THE PORT DID NOT RECOGNIZE THE FIBER. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913272 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657505975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown