BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LASER

    MDR report key: 16436954 · Received February 24, 2023

    Report

    Report Number
    2028159-2023-00247
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 11, 2023
    Report Date
    May 11, 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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM AND REPLICATE THE REPORTED EVENT. THE CORE LASER MODULE WAS REPLACED TO ADDRESS THE ISSUE. 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 ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE NONCONFORMING CORE MODULE. 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).

    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: 2023-13383.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT OPHTHALMIC LASER HAD LOW LASER POWER OUTPUT DURING SURGERY. THE CUSTOMER REALIZED THE POWER OUTPUT WAS LESS, SO HE HAD TO WORK ON THE HIGHER POWER TO GET THE DESIRED EFFECT. THE PROCEDURE COMPLETED BY INCREASING THE LASER POWER. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858580 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657505975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown