BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFLUORON

    MDR report key: 11657765 · Received April 13, 2021

    Report

    Report Number
    1610287-2021-00007
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE COMPLAINT HISTORY SHOWS NO SIMILAR COMPLAINT REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MANUFACTURING BATCH RECORDS (MBRS) SHOWED NO ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO NONCONFORMANCE'S WERE NOTED IN THE MBRS. REVIEW OF THE INCOMING COMPONENT QA INSPECTION REPORTS SHOWED TO BE ACCEPTABLE. ALL FINISHED PRODUCT TESTING RESULTS MET SPECIFICATIONS. THE REPORTED PRODUCT IS MANUFACTURED ACCORDING TO REQUIREMENTS PER THE PRODUCT'S DEVICE MASTER RECORD. THE PRODUCT IS STERILIZED VIA FILTRATION THROUGH STERILIZED SILASTIC TUBING FILLED INTO DRY HEAT STERILIZED VIALS USING A PERISTALTIC PUMP. FINISHED PRODUCT TESTING INCLUDES INFRARED ADSORPTION, UF ABSORPTION, MNR, PURITY OF PRODUCT VIA GAS CHROMATOGRAPHY, PARTICULATE ANALYSIS, BIOBURDEN AND STERILITY. ALL TESTING FOR THE BATCH ASSOCIATED WITH THE REPORTED LOT MET SPECIFICATIONS. THE PRODUCT INSERT PROVIDES INDICATIONS, INSTRUCTIONS, AND STORAGE CONDITION. CUSTOMER PRODUCT STORAGE AND USE COULD NOT BE CONFIRMED. THE REPORTED PRODUCT LABELING PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. INSTRUCTIONS ALSO STATE, ¿ALL COMPONENTS FOR SINGLE USE ONLY.¿ ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES INCLUDE: SOLUTION QUALITY ISSUE UNLIKELY, AS CHEMISTRY AND MICROBIOLOGY DATA WAS REVIEWED AND WAS FOUND TO HAVE MET REGULATORY REQUIREMENTS PRIOR TO RELEASE. NONCONFORMANCE WITH THE KIT SYRINGE, FILTER, OR CANNULA; THE RESULTS OF THE INCOMING INSPECTION MET SPECIFICATIONS FOR EACH OF THESE COMPONENT. CONSUMER MISHANDLING - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF CONSUMER MISHANDLING AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT RELATED TO CONSUMER PHYSIOLOGY ¿ NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF UNIQUE CONSUMER PHYSIOLOGY AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. SURGICAL PRACTICES CANNOT BE CONFIRMED, (E.G. DURING INJECTION, ETC.). A COMPREHENSIVE REVIEW WAS PERFORMED INCLUDING REVIEW OF THE MBRS, COMPLAINT HISTORY, SANITIZATION RECORDS, BIOBURDEN RECORDS, STABILITY DATA, INCOMING COMPONENT INSPECTION RESULTS, IN PROCESS FINISHED PRODUCTS AND ENVIRONMENTAL/UTILITY SAMPLES. THE REVIEW SHOWS THAT THE MANUFACTURING PROCESSES WERE IN A STATE OF CONTROL. BASED ON ACCEPTABLE MBR REVIEW, INCOMING COMPONENT QA INSPECTION TESTING RESULTS, AND FINISHED PRODUCT INSPECTION RESULTS, THIS LOT CONTINUES TO BE ACCEPTABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT AN OPHTHALMIC HEAVY LIQUID WAS INSTILLED INTO A PATIENT'S EYE DURING A PARS PLANA VITRECTOMY SURGERY IN WHICH ADVERSE TOXIC EFFECTS TO INCLUDE OCCLUSIVE RETINAL VASCULITIS ACCOMPANIED BY RETINAL ISCHEMIA AND A MARKED DECREASE IN VISUAL ACUITY OCCURRED WITHIN 24 HOURS AFTER THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION IS NOT AVAILABLE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554785 PERFLUORON FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA 1077M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other