U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Keratome, ac-powered - Product Code HNO
Causa
The ml 7090 calibrated lasik blade (clb) will not fit into the amo amadeus metal blade holder.
Acción
The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Laser, ophthalmic - Product Code HQF
Causa
The spot size control of the scan delivery unit of the mc-500 multicolor laser photocoagulator may turn by itself.
Acción
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plug, punctum - Product Code LZU
Causa
Moisture level may cause the visiplugst (or collasyn plugs) to break apart, or crumble upon contact. the firm's data also suggests that a 4 year shelf
life may not be sustained.
Acción
The firm notified their foreign consignees on 11/26/14. The firm made a decision to conduct a domestic recall on 12/4/14 and will notify US consignees
Consignees will be provided with a return label and request any devices that they still have be returned to the firm.
Any consignees that have gone out of business will be sent a certified letter to their last known address.
CORRECTIVE ACTIONS:
The firm has halted sales of the device until the drying method can be improved. Any remaining stock has been placed in quarantine and will be scrapped.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Laser, ophthalmic - Product Code HQF
Causa
The devices were not shipped with the starter kits.
Acción
Notification letters dated December 18, 2014 were sent to all direct account s(customers). The letters were included with the Starter Kit referred to in the Surgical Procedure Manual.
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
AMO voluntarily recalls COMPLETE® MoisturePLUS maintenance solutions. This recall follows a report by the American Center for Disease Control and Prevention (CDC), where the risk of Acanthamoeba keratitis (current water amoeba) for users of this solution is estimated to be seven times higher (2 cases per year). million) for non-users. Although no contamination of the product has been established to date, and the risk of infection is very low, AMO, as a precautionary measure, recommends to patients to change maintenance solution while waiting for further information. This recall does not apply to other AMO products. The competent authorities have been informed by the company. This message is intended for pharmacists, ophthalmologists (01/06/2007) (110 ko) and opticians (01/06/2007) (113 ko).
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.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
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.