Consumers and health professionals are advised that IQ Medical, in consultation with the TGA, is issuing a safety alert regarding its Fluoron EasyGas.
A mislabelling issue means that some patients, on whom the gas has been used, may need to extend the time that they avoid large air pressure changes, such as that experienced during air travel.
IQ Medical is also undertaking a recall of mislabelled gas syringes from affected lots supplied to hospitals.
Fluoron EasyGas is used in certain eye operations, usually involving surgery on the retina, to maintain pressure in the eye for a period following the procedure until the eye heals. This procedure is known as a tamponade. The type of gas used as a tamponade affects the time that the gas is retained in the eye. The Fluoron EasyGas range includes two gases. One gas is retained for up to 15 days before dissipating, and the other is retained for up to 60 days. During those periods patients are advised not to engage in activities that involve changes in air pressure such as air travel and diving, or to undergo anaesthesia using nitrous oxide. Air pressure changes during the exclusion period will not cause injury but may result in severe eye pain.
Due to an incorrect labelling by the manufacturer, the longer-acting gas may have been used in some patients instead of the shorter-acting one, and these people may not be aware of the extended need to avoid changes in air pressure or anaesthesia using nitrous oxide.
Information for consumers
IQ Medical has contacted hospitals using Fluoron EasyGas from the affected lots advising them of this issue and asking them to contact affected patients.
If you or someone you care for has undergone an eye procedure involving use of gas to pressurise the eyeball, be aware of this issue. If you have any questions or concerns contact your treating ophthalmologist or hospital.
If the person who has had the procedure experiences any pain they should seek prompt medical attention.
Information for all health professionals
Affected patients will be informed about this issue by their treating ophthalmologist or the hospital where the surgery was performed.
If you are treating a patient who has undergone a procedure involving an intraocular tamponade, advise them of this issue. If they have any questions or concerns, refer them to their treating ophthalmologist.
Information for ophthalmologists and hospitals
Ophthalmologists and hospitals have been requested to check their stocks of Fluoron EasyGas to ascertain if they are among affected batches. This issue relates to the potential incorrect bottling of the longer-acting gas C3F8 (12%) instead of SF6 (20%). The affected batches are EG1 300614 and EG1 150714 labelled as SF6 (20%).
If patients have been treated using affected batches, they should be contacted and advised to avoid activities that involve changes in air pressure, as well as to avoid undergoing anaesthesia using nitrous oxide, for the appropriate post-operative period, in this case 60 days.
IQ Medical has contacted hospitals which have been supplied with the gas advising them of this issue and arranging for return and replacement of affected Fluoron EasyGas batches.
If you have any questions or concerns, or need to arrange return of affected stock, telephone IQ Medical on 08 8357 8022 or email admin@iqmedical.com.au.
Reporting problems
onsumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.