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.

According to information from the manufacturer of the product (Abbott Medical Optics Inc.), the use of ophthalmic solution with pH above 8.5 can cause endothelial damage to the cells of the eye. According to the record holder, there is currently no adverse event information related to the problem. Anvisa's Technovigilance Unit is monitoring this case.

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.

According to information presented by the product registration holder, the lens problem was caused by a recent change in the production process, which has already been corrected to avoid further problems. The recall in question only affects Tecnis Model ZCB00 lenses with the expiration dates quoted in this alert (see Product Description field). Anvisa's Technovigilance Unit is monitoring this case.

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.

The company states that it has not received any complaints about this product. Anvisa has no record of adverse event reports or technical complaints regarding this product.

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.

This action in the field follows the Safety Alert issued by Boston Scientific on October 6, 2009. Boston Scientific is taking this additional action after consulting the United States Department of Food and Drug Administration. The original Safety Alert informed users about the potential for degradation of a distal section of the catheter after exposure to UV light (eg sunlight) or fluorescent light (eg office light) and reminded them to store the according to the instructions for use, namely, "Store the catheters in a cool, dry and dark area." If stored in your box and used in accordance with the Instructions for Use, the Guider Softip Guide Catheter will to the performance specifications throughout the validity period indicated on the labeling. If exposed to ultraviolet light or fluorescent light out of the box during the storage period, a portion of the catheter may degrade, which could adversely affect the performance of the device and potentially expose patients to serious risks, including delay at the time of the procedure, due to catheter replacement, vascular trauma and apoplexy. Therefore, DO NOT USE any Guider catheters that have been stored out of the box. Boston Scientific is conducting voluntary recall for all products from customers outside the United States. Anvisa is following this action. Please refer to the attached list of Affected Products. The Guider catheters listed in the attachment should be returned for replacement. #### Update: The field action (recall) was terminated in January 2009, as communicated by UTVIG (on 01/26/2011) of Boston Scientific do Brasil Ltda. The company sold 7,165 units of the product in Brazil and collected 341 units (4.6%), which were sent to the distribution center in the United States of America, according to the documentation sent by the company.

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.

Cardiac Science Corporation has initiated a voluntary field action for POWERHEART automatic defibrillators due to a problem that affects the electronic components of some of these devices. According to information received by the Anvisa Technovigilance Unit (UTVIG / ANVISA), the problem may be related to the operation of resistors that equip the defibrillators. In order to correct the problem, Cardiac Science Corporation has already started the development of a software update for the affected equipment, which should be installed in the equipment that is in the field as of May 2010. The UTVIG / ANVISA has already initiated contact with the holders of product registration in Brazil and is following up on this case.

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.

Glaxo Smith Kline Brazil Ltda (GSK Consumer Healthcare Brasil) has informed Anvisa that, according to research from the medical literature, the inadequate use of zinc-containing dental prosthesis fixatives over the years may lead to the development of neurological symptoms. The cases reported in the recent medical literature (Hedera, 2009; Nations, 2008) are associated with the consumption of 2 or 3 tubes per week, for a total of 330mg, that is, more than 10 times the maximum tolerated intake. The symptoms reported may include numbness, tingling or weakness in the arms and legs, difficulty walking and balance, and blood problems (such as anemia). In Brazil, in the company's database, there are no reports of events of this nature. Likewise, in Anvisa's databases there are no notifications associated with said product. According to GSK Consumer Healthcare Brazil, the reports mentioned are almost exclusively restricted to the United States (n = 409), where the product has been marketed since 1995, with an increase in cases in 2009 (n = 365), compared to a total of 416 reports of these adverse events in the world. The cases reported in the recent medical literature (Hedera 2009, Nations 2008) are associated with the consumption of 2 or 3 tubes weekly, with doses of 330mg, more than 10 times the maximum tolerated intake, for a period of more than 7 years. In Brazil, the Ultra Corega product ANTI-PARTICULATES has been marketed for a year and there are no reports to the company of serious adverse events related to the excessive and prolonged use of the zinc-containing prosthesis fixative. In addition, the product formula registered in Brazil contains 17% less zinc than the options available in the US market and the commercial presentations are tubes of 40g and 20g, therefore smaller than the American version of 68g. ANVISA's Technovigilance Unit is following up on this case. #### TERMINATION OF THE SHARING - 10/30/2010 - On time - The company confirms the destruction of its remaining stock through certificates HTZ0003185 / 2010 and HTZ0003186 / 2010, issued by the company HAZTEC Tecnologia e Planejamento Ambiental S / A and the Closing Letter of Marketing of the Product, as agreed in Meeting in this Agency on 02/23/2010. ####

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.

Medtronic Inc. (headquarters of Medtronic Commercial Ltd.) received 62 reports - out of a total of approximately 110,000 devices worldwide - which indicated that the device interrogation battery voltage was below the stipulated voltage for the device to display the notification of selective substitution indicator (ERI). The measurement of a lower voltage has provoked some questions and, in some situations, it was reason to explain the pacemaker. If the previously mentioned software update is not performed, there is a potential risk of loss of function in a small percentage of devices (less than 0.08% six years after implantation). According to the company, this risk should be eliminated with the software update. Medtronic also identified a faster (than battery) voltage reduction due to the lithium depletion at a slightly faster rate. This subject has not yet been observed in the clinical setting and is not expected to occur within the next 4 years (9 years after implantation). If the previously mentioned software update is not performed, the potential risk of therapeutic loss during or near the ERI / RRT warning may be verified in a reduced number of devices. According to the company, updating the software will eliminate this risk, as it will change the ERI / RRT warning criteria. #### UPDATE (01/11/2011): The company reported (file # 902973 / 11-7) that the action was finalized at the end of 2010 (software update) and presented updated patient control recommendations . Such information can be viewed at http://portal.anvisa.gov.br/wps/wcm/connect/acaf128048ee03f3980c9c466b74119d/Alerta_1005_Orientacoes_Complementares.pdf?MOD=AJPERES.

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.

The manufacturer of the product (Boston Scientific) has concluded, after analysis, that the link between the head and the housing of the aforementioned equipment can be weakened by significant forces associated with the sub-pectoral implant procedure or when such a device already implanted, is pressed against a rib - which occurs during contraction of the patient's pectoral muscle. A weakened head link may alter electrode impedance and produce noise, which may inhibit pacemaker stimulation or initiate inadequate therapy for tachycardia. In addition, additional mechanical wear applied on a weakened link may eventually lead to fracture of the connecting wires of the head, resulting in loss of therapy. The clinical implications are as follows: (1) Significant changes in electrode impedance measurement; (2) Noise, in real time or in accumulated electrograms; (3) Intermittent pacemaker inhibition; (4) Anti-tachycardia pacing, or inappropriate shock therapy; (5) Pacing pacing output block; (6) Blockade of anti-tachycardia and shock therapy stimulation.

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.

1- To the Medical Officer: Share this information with the right people in your lab, save a copy in your files, and pass it on to all sectors that may be using the product, including the units to which you may have sent units of those lots . 2- Users of CLSI and EUCAST 2017 clinical guidelines may continue to use the Ertapenem E-test blister pack (Ref. 531600), except for the Streptococci group, including S. pneumoniae strains. 3- Among the tests performed previously, we ask you to identify possible false positive results, analyze the related risks and determine the appropriate actions, if revelevangtes. 4- Contact bioMérieux for product compensation if necessary. 5- Return the Confirmation of receipt of the guidance letter (Annex A of the letter) to confirm receipt of the notification. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.

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.

According to the record holder, the internal batteries (in conjunction with the battery system controller) may cause the internal battery controller to trigger the safety mode of the equipment and, as a consequence, turn on a high priority alarm. In this case the alarm would be triggered unnecessarily, which can lead to an incorrect decision making on the part of the users. Anvisa's Technovigilance Unit is following up on this case. #### UPDATE (07/04/2011): The company sent a communication to UTVIG / ANVISA (Expediente: 585270 / 10-6) informing the finalization of corrective actions. According to the company, all equipment at risk in Brazil (36 units) were corrected (battery replacement). The company sent copies of the Service Orders corresponding to the correction services. Related documents: NOTIVISA 2010.04.000814, Files 054579 / 10-1 and 585270 / 10-6.

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.

According to information received by Anvisa, the suspension occurred due to non-compliance observed in the item 'thickness' during the analysis carried out by Instituto Falcão Bauer da Qualidade laboratory. According to RDC 05, dated February 15, 2008, the certification of gloves is a prerequisite for its commercialization. #### Update (03/15/2010): Anvisa's RE 1000/2010 suspends import, distribution, trade and use of the product cited in this alert.

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.

The company said it is already developing changes in the instruction manual and product software to reduce the potential incidence of AVIP due to user or user misuse. For more details, see the annexes to this alert: http://portal.anvisa.gov.br/wps/wcm/connect/a5665b8041c553a39e9cdf255d42da10/Carta+ao+cliente.pdf?MOD=AJPERES and http: //portal.anvisa .gov.br / wps / wcm / connect / 3ec16a8041c554959eacdf255d42da10 / Annex + about + AVIP.pdf? MOD = AJPERES. Anvisa's Technovigilance Unit is monitoring this case.

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.

According to the company, the incidents caused by the defect may be high risk, but to date there has been no report or complaint about Bausch & Lomb products marketed in Brazil or any other country.

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.

Since this is an intermittent fault, no solution is available and no action can be taken by the user to prevent the fault from occurring. If the problem occurs, the System should be rebooted either hot or cold. (see instructions for use) If this does not work, Local Assistance should be contacted. If you need additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Call Monday to Friday and Saturdays from 7:00 a.m. to 7:00 p.m. Anvisa is following this action.

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.

It is important to note that the diagnosis of warts is not so simple. Inappropriate manipulation of certain lesions, mistaken for warts (such as nevus (pints) or malignant tumors), may impair treatment or interfere with prognosis. Therefore, it is fundamental that consumers of this type of product exercise extreme caution when self-applying. Anvisa is monitoring through the Sentinel Network all the events associated with these products.

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.

According to the registry holder, a letter was sent to its distributors informing them of the suspension of distribution, trade and use. #### Update: On 08/28/2010, registration no. 80371250003 of the product "Divided Peak Intervertebral Stabilizer Plate" was canceled by Anvisa. #### Update: 10/19/2011 - The company forwards the electronic document with the measures implemented and in progress stated in the Action Plan, for the collection and destruction of all affected products.

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.

Anvisa decided to suspend the marketing, distribution, importation and use of breast implants manufactured by the French company Poly Implant Prothese (PIP) through Resolution RE 1558/2010 (of April 1, 2010) throughout Brazil. The suspension was due to the risk associated with the products mentioned. The holder of the registration in Brazil is the company EMI Importação e Distribuição Ltda. Over the past three years, the French Agency for Sanitary Safety of Health Products (AFFSAPS) has seen an increase in reports of rupture of breast implants manufactured by Poly Implant Prothese. The rupture of the envelope of a mammary prosthesis can lead to local complications in the patients, often requiring surgery to correct the problem. After an inspection at the Poly Implant Prothese plant, AFSSAPS found that the gel filled the prosthesis manufactured by the company was different from that reported in the technical documentation of the product - documentation sent to AFSSAPS at the time of CE certification of the products. Therefore, prostheses do not comply with Directive 93/42 / EC (European Community). In addition, the AFSSAPS identified that the prostheses manufactured by the company are in disagreement with the ASTM F 703 standard, presenting a greater probability of diffusion of silicone through the prosthesis membrane. According to the French agency, this may explain the increase in the number of reports of rupture associated with these breast implants. Regarding Brazil, Anvisa has not, to the present moment, reports of adverse events or technical complaints involving these breast implants in its database of notifications (NOTIVISA). The Technovigilance Unit is following this case with the registration holder. #### Update: AFSSAPS announced on September 28, 2010 a statement on the test results, performed between June and September 2010, regarding the silicone gel used in PIP prostheses. According to the statement from the French agency: (1) Cytotoxicity tests have shown that the silicone gel of PIP prostheses has no toxic effect on tissues; (2) Intradermal irritation tests showed that the gel of PIP prostheses is more susceptible to causing intradermal irritations in patients when compared to other brands of silicone prosthesis; (3) One of the tests of mechanical resistance (elongation to rupture) performed for the envelope (external material of the prosthesis) showed an out-of-specification test, showing that it was a more fragile material than usual; (4) Genotoxicity tests have not yet been finalized by the French agency - the disclosure of results by AFSSAPS is scheduled for early 2011. For people who have PIP implants implanted and who, in the last 6 (six) months, have not undergone examinations ultrasound monitoring, it is recommended to perform this type of examination (ultrasound) to check the state of the implanted prosthesis. The remaining recommendations for users are retained (see the Action Description field in this alert). #### Update: The results of the genotoxicity tests performed by AFSSAPS were released on 04/14/2011 and no cytotoxic or genotoxic effects were observed in the in vitro tests. The results of genotoxic effects tests were not conclusive in in vivo tests. The in vivo intradermal irritation assessment tests for the PIP silicone gel showed that it has a higher irritating power relative to other silicone gel brands. For more recent information on the case, consult the Alert of Technovigilância n ° 1107, available at http://www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=1107.

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.

Abroad, some of the manufacturer's clients reported serious adverse events, which may be related to Shiley cuff tracheostomy tubes - the cuff does not retain leaking air in the inflation envelope of the pilot balloon. The codes affected by the recall in the Brazilian market are listed in the Product Description field of this alert. Batch numbers are formed by the sequence AAMMXXXXXX, where AA is the year, MM is the month, and XXXXXX is a sequential number.

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.

According to Siemens Healthcare, internal regression comparison tests for affected lots showed a deviation of approximately 30% (lower than expected, according to the instructions for use of the product). The quality control of the product did not present this deviation, for the lots submitted to the tests.