Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 recall data from the U.S. and Andorra.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Alcon has identified an insufficient seal on the outside packaging that could potentially affect the sterility of the product. the use of non-sterile vitrectomy probes in surgery has the potential to result in patient infection or inflammation and may lead to serious injury and sequelae, including loss of vision.. at this time, no adverse events or complaints have been confirmed related to the accurus vitrectomy probe lots impacted by this issue. regular post-operative patient follow-up may enable the surgeon to detect early potential abnormal inflammatory reaction and/or infection, which may reduce the severity of the ensuing event.
Acción
Customers are advised to immediately stop further use of the affected lots and to segregate them to ensure that they are not used. Alcon will provide reimbursement for all returned product This action has been closed-out on 9/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Inspections findings by the fda noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. no injuries have been reported for viscocel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
Acción
Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Forum is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. it is intended to work with other forum applications.Forum correctly displays the optical coherence tomogram (oct) retinal b-scan when initially rendered, but a different b-scan tomogram is potentially displayed on subsequent renderings within a user session.Therefore, in certain circumstances an incorrect oct retinal b-scan tomogram scan may be displayed when retrospectively reviewing the available scans.This gives rise to a risk of a healthcare professional making a medical decision for the patient after viewing the wrong scan to what they requested.No incidents have been reported in australia or new zealand.
Acción
An initial workaround is provided to users in the Customer Letter whilst a permanent Software fix is being developed for rollout in February 2015. This action has been closed-out on 18/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Inova has identified an issue with two lots of the ez-load lens delivery system ez-28v, an intraocular lens inserter used to insert sofport intraocular lenses (iols). some inserters have been found to have a hook-like flash located near the tip area. this flash catches the leading haptic causing a kink. whilst mildly bent haptics can be restored to acceptable configuration intra-operatively using surgical instruments, a severely kinked haptic which cannot be restored can result in injury to the intraocular structures.
Acción
iNova is advising users to inspect their stock of EZ-Load Lens Delivery System (EZ-28V) immediately and quarantine any affected lots. iNova will arrange for stock collection and will issue credit for returned stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Inova pharmaceuticals (australia) pty ltd (inova) is conducting an urgent recall of 82 lots of 11 laseredge knife skus used in ophthalmic surgery due to an atypical number of dull blade complaints. if excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.Patients undergoing posterior segment surgery (e.G. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. the likelihood of adverse events associated with dull blades is very low.
Acción
Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The operating instructions for sterilisation (version 2) were either missing or obsolete. the new operating instructions (version 3) contain specific time and temperature for sterilisation. failure to follow the new operating instructions may result in potential adverse events, including eye infections.
Acción
iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017.
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.
Notas adicionales en la data
The company informs that this field action is in a global scope and that there was no receipt of any claim in Brazil. Further informs that this recall does not apply to cannulae with 8 digit lot numbers packed with the Amvisc Plus product; also does not apply to the viscoelastic contained in the glass syringes of the Amvisc Plus product. To date, no notifications have been identified in the NOTIVISA. UPDATE: The company updated the information on 1/30/2013 and added two more batches affected by the field action: D100016A and D090105D. For more information, please contact Customer Service at 08007026464, or e-mail: maria.iung@bausch.com
Causa
Bausch + lomb, inc. recently identified that some disposable canisters (with a 4-digit batch number) supplied with the dvo amvisc plus are not fitting properly to the luer-lock in the sterile glass syringes of amvisc plus. disposable cannulae with 4-digit lot numbers may leak viscoelastic material or dislodge the syringe during injection. the immediate consequence of cannula detachment during intraocular use could involve damage to the intraocular tissue, which may or may not have far-reaching consequences, depending on the specific tissue involved and the nature of the injury.
Acción
Discontinue use of the affected lots of Amvisc Plus DVO immediately.
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.
Notas adicionales en la data
To date, there are no records of product-related notifications in the National Notification System for Health Surveillance - NOTIVISA. Anvisa is following this action.
Causa
The manufacturer of the product has identified the presence of silicone residue in batches of the products mentioned, which can cause from oversight or discomfort to severe eye pain or injury requiring medical treatment. symptoms, however, may vary from individual to individual.
Acción
For professional ophthalmologists and distributors, the company determines that affected lots are identified and segregated. To the patients, the search of their doctor for judicious evaluation.
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.
Notas adicionales en la data
The National Health Surveillance Agency - Anvisa - hereby informs that, to date, there is no report of adverse reactions involving this product in its Database of Notifications of Adverse Events of Health Products. The company BL Indústria Ótica Ltda reported that in Brazil there is, as of today, no case of Fesarium infection involving the product ReNu with Moisture LOC - Multiação Solution. Anvisa will continue to follow the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.//////////Additional information access: http: // www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/822.htm
Causa
The us food and drug administration (fda) and the us centers for disease control and prevention (cdc) have published on the fda website at http://www.Fda.Gov/bbs/topics/news/2006/ new01354.Html, an alert to healthcare professionals and contact lens wearers about the growing number of eye infections caused by the fusarium fungus in the united states. although not so frequent in that country, this type of infection is serious, since it can cause permanent blindness. according to the article, some patients reported loss of vision, requiring corneal transplantation. the fda and the cdc are investigating 109 cases of suspected fusarium contamination in 17 us states. the cause has not yet been detected. of the 30 cases investigated, 28 were users of contact lenses and 2 were non-users. of the 28 users, 26 reported using the product contact lens solution brand renu moisture loc, manufactured by the american company bausch & lomb, or a generic company of the same company, within a month before presenting the infection. five other users reported having used other solutions concurrently, and nine patients reported sleeping with their lenses. the alert highlights cases of corneal infection with fusarium fungus in asia in contact lens wearers in november 2005. in february 2006, bausch & lomb voluntarily suspended the sale of renu multipurpose solutions in singapore and hong kong, after the various notifications of infection among contact lens wearers. in brazil the product renu is imported and distributed by the company bl indústria ótica ltda - baush & lomb.
Acción
- In the United States, the CDC is working on investigations with the company Bausch & Lomb to identify other possible causes, in order to act in the prevention and control of this type of infection. - The American Bausch & Lomb Company informed the FDA that it voluntarily halted the marketing of the product ReNu Moisture Loc during the investigation process and requested that all users of contact lenses that make use of the product in question be careful and report to their respective ophthalmologists any signs or symptoms of eye infection. - In Brazil, BL Indústria Ótica Ltda informed Anvisa that it will take the following preventive / corrective actions in relation to the investigation process, which is in progress: 1) Adoption of control measures in the Brazilian territory, implying the suspension of the commercialization of the product in Brazil until the conclusion of the investigations; 2) Send samples of lots that are in the company's stock, for analysis in an external laboratory; 2) Availability, until Monday, April 17, of information on the company's website including a release with the main information. This release is being passed on to all the commercial area of the company BL Indústria Ótica Ltda., For visits to the main clients, aiming to clarify doubts; 3) Definition, until April 17, 2006, of new strategies of action, for the products that are in the stock of the company; 4) Preparation of a document explaining the situation and training of all its SAC team, in order to support the questions and doubts coming from consumers. The company informs that all the contacts are being registered by the SAC and that to the moment no complaint is related to the appearance of fungi. 5) Communication to Anvisa of new facts that affect the current strategy for the treatment of this situation.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a product withdrawal carried out by ALCON. The users concerned received the attached mail (31/08/2018) (747 KB). This safety action is registered at ANSM under the number R1814668.