Events

Safety Alert for HYDROSOF INTRA-OCULAR LENS ALCON MODEL SH 30 BC

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ALCON LABORATÓRIOS DO BRASIL LTDA.

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
    142
  • Date
    2001-10-18
  • 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 REPORTS THAT IT TAKES CLARIFICATION MEASURES TO ITS CLIENTS IN THE SENSE THAT ALL PATIENTS WHO HAVE BEEN IN THE IMPLEMENTED HYDROSOF IOL ARE EXAMINED IN PERIODIC INTERVALS TO DETERMINE IF THERE IS A DECREASE THAT IS AFFECTING THE QUALITY OF THE VISION. AND THAT THE CASES WILL BE REPORTED TO ALCON. IT WILL BE CONTACTED BY THE CUSTOMER SERVICE WHICH IS SENDING TO YOU A LETTER THE RETURN FORM TO BE COMPLETED AND DELIVERED TO THE CARRIER AGENT THAT ALCON SHALL SEND SOON TO REMOVE / REVOKE YOUR REMAINING STOCK, IN THIS CASE THERE IS NO REMAINING STOCK ... YOU SHOULD FAX THE FORM COMPLETED WITH ZERO, AS INSTRUCTED IN THE SAME, AS WELL AS THE SECOND WAY OF THE LETTER. -------------------------------------------------- ----------------- ALCON COMMUNICATION - JULY 17, 2002 - NOTIFY THAT ALL LEGAL PROCEDURES HAVE BEEN COMPLIED WITH THE PROCESS OF COLLECTION OF THE HYDROSOF SH30BC INTRA-OCULAR LENS, HAVING HELD NO DAY 17.04.2002
  • Reason
    Reports on a possible problem with the sh 30bc model of the hydrosof intra-ocular lens. two clinics in brazil reported an excessive level of capsular fibrosis before approximately 45-60 days after surgery, causing the decentration of lenses in some patients. in some cases this can affect the patient's vision in a negative mode. secondary surgical procedures may be needed to replace or replace the intraocular lens and these may cause other complications.
  • Action
    STILL TO BE NOT ESTABLISHED IF THE PROBLEM IS RELATED TO THE LENS, THE COMPANY IS REQUESTING SURGERIES TO DISCONTINUE THE HYDROSOF IMPLANT PROCEDURE AND RETURN THE REMOTE STOCK FOR ALCON. IT IS RECOMMENDED THAT ALL PATIENTS WHO HAD THE IMPLANTED HYDROSOF IOL BE EXAMINED AT PERIODIC INTERVALS TO DETERMINE THAT THERE IS A DECREASE THAT IS AFFECTING THE QUALITY OF THE VISION AND THAT THOSE CASES ARE REPORTED TO ALCON. RECOMMENDATIONS FOR RETURN / EXCHANGE ... YOU WILL BE CONTAINED BY THE CUSTOMER SERVICE THAT YOU ARE SENDING TO A LETTER THE RETURN FORM TO BE COMPLETED AND DELIVERED TO THE TRANSPORTATION AGENT THAT ALCON SHALL SUBMIT SOON TO REMOVE / REPLACE YOUR STOCK REMANESCENT, IN THIS CASE THERE IS NO REMAINING STOCK ... YOU SHOULD FAX THE FORM COMPLETED WITH ZERO, AS INSTRUCTED IN THE SAME, AS WELL AS THE SECOND WAY OF THE LETTER. REPORT THROUGH THE PHONE 0800-7077993 OR PICK YOUR DAMAGES.

Device

HYDROSOF INTRA-OCULAR LENS ALCON MODEL SH 30 BC

Manufacturer

ALCON LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA