BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFLUORON

    MDR report key: 24399231 · Received February 20, 2026

    Report

    Report Number
    1610287-2026-00004
    Event Type
    Death
    Date Received
    February 20, 2026
    Date of Event
    January 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LWL
    UDI-DI
    00380659001130
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS H6 AND H11. NO PHOTO(S) AND/OR VIDEO(S) WAS PROVIDED BY THE REPORTER AND A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS BATCH/LOT WAS PERFORMED AGAINST BOTH FILLING AND PACKAGING LOTS. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE BATCH/LOT UNDER INVESTIGATION. REVIEW OF THE PACKAGING MANUFACTURING BATCH RECORDS (MBRS) FOR THIS PACKAGING LOT DID NOT SHOW ANY ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON REPORTED COMPLAINTS, THIS LOT CONTINUES TO MEET THE ESTABLISHED ACCEPTANCE CRITERIA. A NON-CONFORMANCE BASED REVIEW OF THE BATCH/LOT WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. A REVIEW OF THE MANUFACTURING BATCH RECORD WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE PRODUCT¿S ACCEPTANCE CRITERIA. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A REVIEW OF PRODUCTION INFORMATION, COMPLAINT HISTORY, AND SERVICING (AS APPLICABLE) WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE COMPLAINT. BASED ON THE INVESTIGATION, A FAILURE OF THE DEVICE, LABELING, OR PACKAGING TO MEET SPECIFICATIONS COULD NOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, AND PENDING THE RESULTS OF THE HOSPITAL INVESTIGATION, THE PRECISE MECHANISM IS NOT YET FULLY CONFIRMED. PER THE TREATING SURGEON¿S REPORT, PERFLUORON POTENTIALLY MIGRATED FROM A CHOROIDAL DEFECT INTO THE SYSTEMIC CIRCULATION, CAUSING AN AIR EMBOLISM. AT THIS TIME, THE EGRESS OF PERFLUOROCARBON CANNOT BE EXCLUDED. CONSISTENT WITH DESCRIPTIONS IN THE LITERATURE, UNINTENTIONAL ENTRY INTO THE OCULAR VENOUS SYSTEM HAS BEEN RECOGNIZED AS A PLAUSIBLE MECHANISM BY WHICH MATERIAL MAY ENTER THE VENOUS DRAINAGE OF THE EYE AND SUBSEQUENTLY REACH THE PULMONARY CIRCULATION, WHERE EMBOLIC OBSTRUCTION CAN OCCUR. UPON FURTHER REVIEW OF LABELING (JAPANESE PACKAGE INSERT), MANUFACTURER JAPAN FOUND THE LABEL/INSERT NEEDED AN ENHANCEMENT IN THE WARNINGS/PRECAUTIONS REGARDING THE POTENTIAL EMBOLISM. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A REEVALUATION OF THE COMPLAINT INVESTIGATION. A COMPREHENSIVE REVIEW WAS PERFORMED OF THE MANUFACTURING FOR THIS LOT INCLUDING A REVIEW OF THE BATCH RECORDS, PRODUCTION PROCESSES, COMPLAINT HISTORY, AND FINISHED PRODUCT INSPECTION RESULTS. THE REVIEW SHOWS THAT THE MANUFACTURING PROCESS WAS IN A STATE OF CONTROL. BASED ON THE ACCEPTABLE MBR REVIEW AND FINISHED PRODUCT INSPECTION RESULTS, THIS PRODUCT LOT CONTINUES TO BE ACCEPTABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    AS INITIALLY RECEIVED BY AN EYE CARE PROFESSIONAL (ECP), A PATIENT¿S CONDITION ¿SUDDENLY CHANGED¿ AFTER SURGERY, ASSOCIATED WITH THE USE OF PERFLUORON FROM ONE OF TWO KNOWN LOT NUMBERS. NO FURTHER DETAILS WERE PROVIDED AND ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ECP CLARIFYING THE EVENT AS A ¿SEVERE AIR EMBOLISM RESEMBLING PERFLUOROCARBON SYNDROME¿ OCCURRING DURING THE WEEK OF SURGERY. NO FURTHER DETAILS WERE PROVIDED AND ADDITIONAL INFORMATION WAS REQUESTED. FURTHER INFORMATION ON THE EVENT WAS RECEIVED FROM THE ECP: DURING A PLANNED SURGERY ON THE RIGHT EYE, PERFLUORON POSSIBLY MIGRATED FROM A CHOROIDAL DEFECT INTO THE PATIENT¿S SYSTEMIC CIRCULATION, RESULTING IN AN AIR EMBOLISM AND THE SUBSEQUENT DEATH OF THE PATIENT. RELEVANT SURGICAL AND EVENT DETAILS WERE REPORTED AS FOLLOWS: IN A CASE WITH EXTENSIVE RETINAL PIGMENT EPITHELIUM (RPE) DEFECTS INVOLVING THE MACULAR REGION (DUE TO AGE-RELATED MACULAR DEGENERATION), THE ECP ATTEMPTED A SUBMACULAR SURGERY IN WHICH RPE TISSUE WAS HARVESTED FROM THE SUPERIOR AREA AND AN AUTOLOGOUS TRANSPLANTATION WAS PERFORMED. AN IATROGENIC RETINAL DETACHMENT WAS CREATED AND PERFLUOROCARBON WAS USED TO STABILIZE THE SURGICALLY CREATED RETINAL DETACHMENT DURING MANIPULATION. SUBSEQUENTLY, PERFLUORON WAS INJECTED ONTO THE RETINAL SURFACE TO REATTACH THE RETINA AND THE SUBRETINAL PERFLUORON WAS ASPIRATED. NO BUBBLES WERE SEEN DURING PERFLUORON ADMINISTRATION AND NO INTRAOPERATIVE RETINAL SLIPPAGE WAS OBSERVED. ONCE THE RETINA WAS FULLY STRETCHED AND THE AUTOLOGOUS TRANSPLANTATION WAS CONSIDERED COMPLETE, THE PERFLUORON WAS ASPIRATED AND AN UNSPECIFIED SILICONE OIL WAS INJECTED, LEAVING NO RESIDUAL PERFLUORON IN THE EYE. IMMEDIATELY AFTER SURGERY, THERE WERE NO CHANGES IN THE PATIENT¿S CONDITION; HOWEVER, FOUR HOURS POST-OP, THE PATIENT DEVELOPED RESPIRATORY DISTRESS FOLLOWED BY CARDIAC ARREST. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INTRODUCED AS PART OF RESUSCITATION EFFORTS, BUT THE PATIENT EXPIRED THE FOLLOWING DAY DUE TO MULTIPLE ORGAN FAILURE. A CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED AFTER ECMO INITIATION, WHICH REVEALED FINDINGS CONSISTENT WITH AIR EMBOLI IN THE HEART AND AORTA. IT WAS ALSO CONFIRMED THAT BOTH LOT NUMBERS INITIALLY REPORTED COULD NOT BE RULED OUT AS THE SUSPECT DEVICE, AS BOTH WERE USED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537281 PERFLUORON FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA 12WH2 00380659001130

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other| D