General description of the device
PFCL, Perfluoro Carbide Liquid, is a class IIa medical device. It is a high-density, low-viscosity liquid intended for tamponade of the vitreous chamber during eye surgery with a maximum residence time in the eye of 1 hour. Following removal, it can be replaced with a long-term buffering medium.
Directions for use.
PFCL is used to tamponade the vitreous chamber after removal of the central and possibly the peripheral vitreous body. Its use is limited to the duration of surgery, and once its action has taken place it must be removed. Its low viscosity allows smooth infusion into the eye through the use of standard instrumentation.
- Do not inject into the vitreous
- Do not use as a vitreous substitute
- Do not leave in situ for any reason.
- Do not use the device for uses other than those indicated.
- The medical device is disposable.
- Use only in sterile field.
- Do not use the product after the expiration date.
- Make sure the packaging is intact: sterility is guaranteed if the packaging is intact. Do not use the device if the packaging is damaged.
- Do not re-sterilize accessories. Re-sterilization could lead to material degradation processes.
- The contained accessories are sterile and disposable. Reuse of accessories can lead to bacterial contamination events, with serious consequences for the patient.
- Make sure that there is no free vitreous that can mix with PFCL
- If the eye is under continuous infusion be sure not to reflux PFCL down the infusion line
- Ensure that there is an escape route while injecting the substance in order to avoid ocular hypertension
- As soon as the washing is done and the liquid and solid residues are removed, remove the substance from the eye within an hour. Dwell time in the eye should be less than 60 minutes
- Perfluorocarbons cannot be mixed with silicone oil.
Vitreoretinal surgeries can lead to postoperative complications. It is the responsibility of the surgeon to properly inform the patient of the risks-benefits of the operation.