Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT PRODUTOS OTICOS LTDA; Abbott Medical Optics, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2015
  • Date
    2016-08-31
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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
  • Reason
    Abbott medical optics inc. (amo) is collecting 737 iols globally from 33 production orders. the number of iols affected by this recall in brazil is 7 lenses. this recall was initiated as a result of a complaint (abroad) involving an unexpected postoperative refractive result associated with improper dioptric lens implantation. as a result of the investigation of the complaint, amo has identified that manufacturing line inspection equipment (miq) has suffered intermittent screen freezes over a period of five years. this inspection equipment measures the power and contrast of diopter as a final control to ensure that optical quality defects, including incorrect resolution and diopter, are rejected. intermittent screen freezing of the inspection equipment can result in diopters or resolution outside the specification being released from the manufacturing site for commercial distribution.
  • Action
    Field Action No. HHE 2016-016 triggered under the responsibility of ABBOTT PRODUCTOS OTICOS LTDA. Company is collecting the product.

Device

Products Affected: 1. Trade name: ACRYLIC INTRAOCULAR LENS - Registration: 80147060069 - Model: A...

Manufacturer

ABBOTT PRODUTOS OTICOS LTDA; Abbott Medical Optics, Inc.