BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM-PAK SURGICAL PROCEDURE PACK

    MDR report key: 22028134 · Received May 15, 2025

    Report

    Report Number
    1644019-2025-01498
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 21, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. PRODUCT EVALUATION WAS NOT ABLE TO BE PERFORMED SINCE THE REPORTED PRODUCT WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. A REVIEW OF THE REPORTED PAK'S BILL OF MATERIALS (BOM) SHOWS THE SUSPECT PRODUCTS ARE 051-0101SMS GOWN,LARGE,NON REINFORCED AND 051-0101SMSTW GOWN,LARGE,NR,W TOWEL,WRAPPED. A REVIEW OF THE DEVIATION HISTORY REPORT SHOWS THIS LOT DID NOT HAVE A TEMPORARY DEVIATION APPLIED ON THE GOWNS. THE SUPPLIER MANUFACTURER INVESTIGATION CONFIRMED THE GOWNS DO NOT CONTAIN LATEX AND ARE THEREFORE SAFE FOR INDIVIDUALS WITH LATEX SENSITIVITIES. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS INCONCLUSIVE. THE INVESTIGATION DETERMINED THERE IS NO RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT. THE INVESTIGATION CONFIRMED THAT THE GOWNS AND THE PAK DID NOT CONTAIN ANY LATEX MATERIALS. NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE FACILITY ENVIRONMENT AND OTHER NON-COMPANY ITEMS THAT ARE PART OF THE SURGICAL SUITE THAT CAME IN CONTACT WITH THE USER DURING THIS REPORTED EVENT. THE ROOT CAUSE FOR THIS COMPLAINT IS NOT KNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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 NURSE REPORTED SKIN BREAKOUT WITH REDNESS, ITCHING, AND RAISED RASH ON THE NECK, CHEST, AND JAW DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE ZYRTEC WAS GIVEN BY MOUTH AND TOPICAL 2.5 HYDROCORTISONE APPLIED TO THE AFFECTED AREAS. THE ITCHING / HIVES WAS CONTINUOUS, ¿COMES AND GOES¿. IT WAS CONFIRMED THAT BOTH TECHNICIANS ARE ALLERGIC TO LATEX. THERE WAS NO REPORT OF IMPACT TO A PATIENT, THE GOWNS ARE BEING USED TO COMPLETE THE PROCEDURES WHILE ON OCCASION THE TECHNICIANS EXPERIENCING THE REPORTED SYMPTOMS. ALL SYMPTOMS WERE RESOLVED THIS REPORT PERTAINS TO 4 OF 4 PATIENT INVOLVED IN THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896867 CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention SURGICAL PRODUCT, UNSPECIFIED