Events

Safety Alert for SOFPORT AO (LL61AO) LENS INTRA-OCULAR ASFERICA, Record number: 80136060093 - Affected lots - Annex I

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BL Industria Otica Ltda; Bausch & Lomb Incorporated.

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
    1601
  • Date
    2015-06-03
  • 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
    The company recommends not to proceed with the implantation of the lens in the patient.
  • Reason
    The company identified an increased incidence of breakage risk in the sofport intraocular lens loop.
  • Action
    The company BL Industria Otica Ltda., Asks all customers to return the product SOFPORT AO (LL61AO) LENS INTRA-OCULAR ASFERICA. The returned lenses will be replaced. Further information - Attachment - Letter to the Client.

Device

SOFPORT AO (LL61AO) LENS INTRA-OCULAR ASFERICA, Record number: 80136060093 - Affected lots - Annex I

Manufacturer

BL Industria Otica Ltda; Bausch & Lomb Incorporated