Alerte De Sécurité sur Products Affected: 1. Trade name: ACRYLIC INTRAOCULAR LENS - Registration: 80147060069 - Model: AR40e - Dioptria 9.0 - Series Affected in Brazil: 2003061505 /// 2. Trade name: TECNIS ACRYLIC LENS - Registration: 80147060093 - Model: ZCB00 - Dioptria 21.0 - Series Affected in Brazil: 4428291206; 4428311206; 4428331206; 4428351206; Inhalation: No known significant effects or critical hazards. Inhalation: No known significant effects or critical hazards. Inhalation: No known significant effects or critical hazards. Inhalation: No known significant effects or critical hazards. Class III: High risk

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 in your inventory the products affected by the recall action (SEE LETTER TO CUSTOMERS): DISCONTINUE the use and remove from your inventory all affected IOLs listed on the attached Customer Response Form. Fill out and return the attached Customer Response Form EVEN IF YOU DO NOT HAVE ANY INVENTORY affected by this recall. Abbott Medical Optics Inc requires this information for reconciliation purposes with regulatory agencies. The Intra-Eye Lens serial number is printed at the end of each unit pack. The IOL serial number is also present on the IOL lens holder inside the package. This notice should be shared with those within your organization who need to be aware or to any organization where the potentially affected products have been transferred. 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