The Spanish Agency for Medicines and Health Products (AEMPS) has scrapped of the market of the Optiben Dry Eyes ophthalmic solution 10ml with number of lot R1033Athanks to the notice of the manufacturer Avizor SA, Spain.
It is a ophthalmic solution for the eye moisturizing and lubrication as the relief of sensation of dryness and eye irritations caused by environmental conditions, fatigue, prolonged work in front of digital devices or the use of contact lenses.
According to the information provided by the company, it has been detected that the packaging of the affected lot may contain Methocela product used as a contact solution between the eye and the lens for diagnostic use in fundus examination with slit lamp, gonioscopy or certain eye treatments.
Using Methocel instead of Optiben it could provoke a allergic reaction in the patient, temporary blurred vision, redness, irritation either stinging among others.
The company is sending, through its distributors in Spain, a warning note to patients, sales and distribution establishments that have the affected product, to inform them of the problem and the actions to follow for the withdrawal of the product.