Field Safety Notice Fluoron GmbH Distributed by Daybreak Medical Ophthalmic Syringe Siluron® Products IVZ871, IV872 and IVZ873 (ICN 2543)

Alert:

• Fluoron GmbH has issued a Field Safety Notice regarding the silicone oil of the type Siluron® 1000, Siluron® 2000 and Siluron® Xtra.
• In some cases, cloudiness has been observed after injection in the affected Lots.
• The opacity presents as a temporary limitation of the patient’s vision. The oil looks cloudy in the eye. Droplets as in emulsification cannot be observed.
• The opacity has no effect on the function of the silicone oil as a tamponade of the retina. Toxic effects or inflammation have not been reported. The patient’s temporary visual limitation remains until the product is explanted and disappears as soon as the oil is removed.

Products Affected:

• The affected products are distributed by Daybreak Medical and are available from NHS Supply Chain eDirect route:

• Please note only the Lot numbers quoted are affected.
• Please see the attached list for potential indirect alternatives.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected lot numbers.
• Contact your local NHS supply Chain Customer Service Advisor with full details of affected products. Your Customer Service Advisor will confirm details and provide you with a unique CMS reference.
• Dispose of the affected products in accordance with your local regulations.
• On receipt of written confirmation, quoting your unique reference number, credit for the full value of product destroyed will be raised.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.