PERFLUORON 0090010015Recalls & reported problems
Alcon Laboratories, Inc. · PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert · Class 3
- Adverse event reports
- 3
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380659001635), received between Sep 13, 2022 and Sep 7, 2026 — classified as 2 deaths, 1 injury.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Air/Gas in Device1
Patient problems
- Cardiac Arrest2
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
DeathSep 7, 2026Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Cardiac Arrest
MAUDE report 50646990 ↗DeathSep 7, 2026Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Cardiac Arrest
MAUDE report 50646840 ↗InjurySep 13, 2022Air/Gas in Device; Air/Gas in Device
A CUSTOMER REPORTED THAT THEY EXPERIENCED THE SINGLE DROP DISPENSING AS MULTIPLE DROPS FOR THE PERFLUORON KIT DUE TO AIR/GAS IN DEVICE. THE PATIENT HAD A VISION PROBLEM (UNKNOWN EYE) AND REQUIRED INTERVENTION.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 15411694 ↗
Other Fluid, Intraocular devices
- SILIKON™ 8065601187Alcon Laboratories, Inc. · Fluid, Intraocular39 reports
- Adato SIL-OL-5000 ES 5000 SBausch & Lomb Incorporated · Fluid, Intraocular1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.