Alerta De Seguridad para ACRYSOF CACHÉT PHAKIC - Models: L12500, L13000, L13500 and L14000. ANVISA registration nº 80147540167

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.

Following discussions with the Medical Advisory Councils, Alcon is developing a plan of action to ensure that physicians hold the necessary information for proper treatment and monitoring of patients and for patients to be able to make informed choices about their treatments. Meanwhile, and until further instructions are issued, Alcon has voluntarily suspended the distribution of AcrySof® CACHET® Easy Intraocular Lenses. Until Alcon finalizes its plans and issues additional instructions, it recommends: • For patients with AcrySof® CACHET® Facial Implant Lenses: o Talk to your patients about the need for strict compliance with the monitoring requirements (cell density endothelial - DCE - monitoring every six months) according to the current and current Instructions for Use. Strict adherence to these requirements by patients will help in the timely identification of ECD and will allow determination of appropriate treatment. Remind these patients of the risks associated with undetected loss of endothelial cell density. o The cause of ECD in individual patients has not yet been fully clarified and is probably multifactorial. However, recent analyzes have indicated a trend towards higher loss rates in:  Patients with smaller eyes (with L12500 model lens implants)  Patients who identified themselves as Asian. In particular, such patients should be informed of the potential risks associated with high ECD rates, and about expressing willingness to adhere to the recommended post-surgical follow-up. o If the patient is waiting for a CACHET® Intraocular Lens Implant for the second eye, please contact your Alcon representative for additional information. • For patients considering implants with CACHET® Intraocular Lens: o There is no provision for the availability of the CACHET® Intraocular Lens, so please inform potential patients that surgeries can not be marked at this time. o If patients wish to wait for the CACHET® Intraocular Lens, we recommend discussing their conditions to determine the suitability of the use and willingness of these patients to comply with the continuous monitoring and evaluations programmed in the Instructions for Use, as well as the potential need for explanations if the requirements are not met. Additional information, contact your surgical sales consultant. Anvisa's Technovigilance Unit is monitoring this case Access to the letter to the prescribing physicians of the Lens: http: //portal.anvisa.gov.br/wps/wcm/connect/f95483804f399417b1b3f9d785749fbd/Modelo_de_Carta.pdf? MOD = AJPERES #### UPDATED 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.