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
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Acción
Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.
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
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.
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.
Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone.
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
Knife, Ophthalmic - Product Code HNN
Causa
Size mislabeled on product handle.
Acción
On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.
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
Sponge, Ophthalmic - Product Code HOZ
Causa
Sterility of the device is compromised.
Acción
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
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
Sponge, Ophthalmic - Product Code HOZ
Causa
Sterility of the device is compromised.
Acción
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
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
Sponge, Ophthalmic - Product Code HOZ
Causa
Sterility of the device is compromised.
Acción
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
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, Battery-Powered - Product Code HMY
Causa
Microkeratome blade may cause irregular corneal flap which may delay patients procedure.
Acción
BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply 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.
The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
Acción
The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.