BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 16928957 · Received May 15, 2023

    Report

    Report Number
    1644019-2023-00557
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 17, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524372
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. ATTACHED PICTURE OF THE PRODUCT AND LOT INFORMATION SEEN ON THE SECOND LABEL MATCHES WHAT WAS REPORTED. THE LOT SEEN ON THE FIRST PAK LABEL DOES NOT MATCH THE REPORTED LOT AND IS ASSOCIATED WITH QS# (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THEREFORE; THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. 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 PHYSICIAN REPORTED THAT THE CUTTER DID NOT SEEM TO BE ASPIRATING PROPERLY, BUT NOT BE CUT OR ASPIRATED PROPERLY DURING VITRECTOMY SURGERY. THE CUT RATE DROPPED TO 5000 CUTS PER MINUTE TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED ON (B)(6) 2023. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662332 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 1502FL 00380657524372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown