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Saudi Food and Drug Authority Alerts From Using Certain Lots of Contact Lens model Avaira Toric and Avaira Sphere produced by Coopervision Inc.

2012-03-25

Saudi Food & Drug Authority would like to alert healthcare practitioners and consumers from using certain lots (limited quantities produced at certain dates)  of contact lens model Avaira Toric and Avaira Sphere , produced by Coopervision Inc’ that may contain Silicon Oil residues, leading to vision distortion or a feeling of foreign bodies in the eye that necessitate medical intervention. The affected product can be distinguished by comparing the lot numbers of the lens with the lot numbers provided in this alert on the outer package or internal lens enclosure ( as shown in the pictures). SFDA made sure that the said lens distributor had recalled the affected lot numbers from the local market.

However, SFDA would like to advice all consumers who may have the affected lot to call their distributor to replace them free of charge and report about any problems or adverse impacts of medical devices and products to the National Center for Medical Devices Reports (NCMDR) at: http://ncmdr.sfda.gov.sa

Consumers may compare the lot number of their contact lenses with the affected lot numbers through the following link: