BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LASER

    MDR report key: 16634976 · Received March 29, 2023

    Report

    Report Number
    2028159-2023-00370
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    November 29, 2022
    Report Date
    May 4, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM AND REPLICATE THE REPORTED EVENT. THE FONT PANEL AND CORE MODULE WERE 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 FALL DAMAGE. MANUFACTURERS 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: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED BEFORE LASER-ASSISTED IN SITU KERATOMILEUSIS SURGERY AN OPHTHALMIC EMBEDDED LASER HAD SHUT DOWN ON ITS OWN. THE SYSTEM WAS UNABLE TO BOOT UP AND A WAS BLACK SCREEN DISPLAYED ALSO THE PANEL WAS BROKEN. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954052 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657505975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown