Alerte De Sécurité sur Trade name: Acuvue Oasys Contact Lenses. Technical Name: Contact Lenses. ANVISA registration number: 80148620058. Risk class: II. Model Affected: N / A. Serial numbers affected: B00GW4Z, B00HRMG

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If you have received a potentially affected product, please follow these instructions: 1. Review your inventory and determine if you have any of the above listed batches of ACUVUE OASYS FOR ASTIGMATISM WITH HYDRACLEAR PLUS; 2. If you have stock of the lots mentioned, we ask that you suspend your marketing. You can continue to market all other lots not affected by this field action; 3. Please give this notice to anyone in your organization who needs to be aware of the field action and make sure they have knowledge as needed; 4. Contact Customer Service at 0800-728-8281 to coordinate the return of affected batches units and free replacement of the product; 5. Complete the response form below, even if there is no affected product in your inventory, and send via email to supportvistakon@conbr.jnj.com or through your JJVC sales representative. JJVC needs this information for reconciliation purposes. As always, any patient who has a complaint about ACUVUE® products is instructed to stop using it and immediately contact Johnson & Johnson Vision Customer Service (0800-762 5424), or the product has been purchased, or your ophthalmologist. If any user experiences persistent irritation, pain or redness, or any change in vision after removal of the lens, the user should contact his physician immediately. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 11/25/2013 - Date of notification notice to Anvisa: 11/24/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "