MAUDE Adverse Event Report: Alcon Research, LLC PERFLUORON; Fluid, intraocular

Catalog Number	0090010015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/01/2026
Type of Reportable Event	Death
Event or Problem Description
A customer via government agency reported that the patient underwent vitreoretinal surgery consisting of a 25-gauge pars plana vitrectomy, membrane peel, silicone oil removal, endolaser photocoagulation, and the use of perfluoro-n-octane (pfo) to manage the underlying retinal condition.Postoperatively, the patient experienced cardiac arrest in the recovery room, resulting in death.The event was reported to be associated with the use of perfluoron from two different lot numbers.No further details were provided and additional information was requested.
Additional Manufacturer Narrative
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.

• Brand Name: PERFLUORON
• Common Device Name: Fluid, intraocular
• Manufacturer (Section D): Alcon Research, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): Alcon Research, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50646990
• Report Number: 1610287-2026-00038
• Device Sequence Number: 10485124
• Product Code: LWL
• UDI-Device Identifier: 00380659001635
• UDI-Public: (01)00380659001635(17)270131(11)240201(10)131U0
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P950018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0090010015
• Device Lot Number: 131U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 02/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 61 LB
• Patient Race: White