BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 12715439 · Received October 28, 2021

    Report

    Report Number
    2028159-2021-01243
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 1, 2021
    Report Date
    May 19, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524518
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF A FRESH RETINAL FORAMEN WAS FOUND WITH LASER TREATMENT; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. 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

    D.3. PRODUCT MANUFACTURING SITE UPDATED DUE TO RECEIPT OF NEW LOT NUMBER. G.9. MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER 1973628. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE POSSIBLE LOT NUMBERS, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBERS 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 CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. AN ACCEPTANCE QUALITY INSPECTION IS PERFORMED TO ENSURE PRODUCT MEETS RELEASE ACCEPTANCE CRITERIA. NON-CONFORMING PRODUCT IS REMOVED FROM THE LOT. 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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A FRESH RETINAL FORAMEN WAS FOUND DURING A FINAL DENTING DURING A PROCEDURE. THE FORAMINA WERE TREATED WITH LASER THE EYE WAS SUPPLIED WITH GAS AND PATIENT HAD TO CAMP. NO HOSPITALIZATION WAS REQUIRED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING DURING THE SURGERY ALL THE 27G AND 25G TROCARS WERE SPONTANEOUSLY LEAKING IMMEDIATELY AFTER INSERTION LEAKED OUT OF THE VALVES. THERE WERE MULTIPLE PRODUCTS REPORTED FROM THE SITE AND IT IS STILL UNKNOWN THIS ACTUAL PRODUCT IS ASSOCIATED WITH THE COMPLAINT. THIS REPORT IS FIRST OF THE THREE REPORTS. THIS ONE REPRESENTS THE 25 GAUGE VALVED TROCARS.

    Additional Manufacturer Narrative · 1

    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 · 1

    A PHYSICIAN REPORTED A FRESH RETINAL FORAMEN WAS FOUND DURING A FINAL DENTING DURING A PROCEDURE. THE FORAMINA WERE TREATED WITH LASER THE EYE WAS SUPPLIED WITH GAS AND PATIENT HAD TO CAMP. NO HOSPITALIZATION WAS REQUIRED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613258 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 2373981H 00380657524518
    1613259 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 2373981H 00380657524518

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention