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
unit, phacofragmentation - Product Code HQC
Causa
Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Acción
The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system.
For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
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
unit, phacofragmentation - Product Code HQC
Causa
Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Acción
The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system.
For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
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
unit, phacofragmentation - Product Code HQC
Causa
Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Acción
The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system.
For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
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
unit, phacofragmentation - Product Code HQC
Causa
Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Acción
The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system.
For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
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 lenses inside the package do not match the prescription information for power labeled on the primary package.
Acción
CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm.
For further information, contact your CIBA Vision sales representative or call 1-877-542-5928.
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 amount of d&c; #6 dye added to the formulation exceeded specified amounts.
Acción
Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notification dated April 20, 2010. Consignees were informed of the issue and asked to identify and return all affected product to the firm.
For further information, contact Bausch & Lomb, Inc. at 1-585-338-5477.
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
A field action was initiated due to a recent customer complaint from japan there is a labeling mixup and that some of the bd visitec edgeahead mvr knife 0.90mm (20g), ref 585230, shelf packs may contain bd visitec edgeahead slit knife 2.3mm (40 degree), ref 8009918.
Acción
BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm.
For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.
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.
Vistakon is recalling acuvue advance for astigmatism diagnostic product for mislabeling.
Acción
Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.
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
Contact Lens Solution - Product Code LPN
Causa
During routine testing the product failed to meet shelf life specifications.
Acción
Consignees were notified by letter on/about August 17, 2009. All consignees were asked to review their inventory and return any of the affected product to Stericycle Pharmaceutical Services.
For questions about the recall process or need additional shipping labels, please contact Stericycle Inc. at 1-888-345-83 16. For questions regarding this recall, please contact Bausch & Lomb's Customer Resource Center at 1-800-828-6974.
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
Ophthalmic Trocar Cannula - Product Code NGY
Causa
Specific lots of alcon 25 ga trocar blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
Acción
Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.
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
Ophthalmic Trocar Cannula - Product Code NGY
Causa
Specific lots of alcon 25 ga trocar blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
Acción
Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.
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
Ophthalmic Laser - Product Code HQF
Causa
Alcon had identified that indications for use unapproved by the food and drug administration are included in the purepoint laser system operator's manual, catalog number 8065751131, revision b.
Acción
An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual:
Updated:
"AMD; Wet or Dry to include macular degeneration" has been updated to read "Choroidal neovascularization secondary to age-related macular degeneration (AMD)".
"Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure
Glaucoma (AACG), and refractory glaucoma" has been updated to read "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma"
Removed:
Macular photocoagulation; including grid, focal, laser drusen scatter (panretinal)
Transcleral cyclophotocoagulation
Intra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastoma
Otosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.
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
needle, phacoemulsification - Product Code NKX
Causa
Sterimed, inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. the removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end.
a breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable.
Acción
Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
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
Ac-Powered Keratome - Product Code HNO
Causa
The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Acción
Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.
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
Opthalmic microsurgical system - Product Code HQC
Causa
Amo initiated this field correction event after becoming aware of a trend in complaints associated with amo vitrectomy cutter used in conjunction with the amo whitestar signature phacoemulsification system. the physician may be unable to make a cut during cataract surgery.
Acción
On April 2, 2008, AMO began distribution of an Urgent Safety Notice to all customers in the United States via overnight carrier (Federal Express). The U.S safety notice was used as a template for all global AMO communications regarding the Urgent Safety Notice , many of which required translation into local language prior to distribution. Included in this correspondence is a listing of the serial numbers of the affected products.
The Notice informed customers of the problem and gave the customers modifications to the Vitrectomy Cutter Priming Instructions. In addition, the notice informed the customers that an AMO Field Service Engineer will be scheduling a site visit to modify a pressure setting on the AMO Whitestar Signature system.
Contact the AMO Phaco Technical support at 1-877-AMO-4LIFE for assistance.
AMO will provide updates to the FDA, including all information regarding the recall effectiveness as part of the recall progress reports.
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
Ac-Powered Keratome - Product Code HNO
Causa
The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Acción
Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.
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
Microkeratome - Product Code HMY
Causa
Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.
Acción
BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.
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
ophthalmic irrigation and aspiration - Product Code KYG
Causa
Plastic shavings are coming from the product
handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
Acción
An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall
Notification Letter are instructions: "In addition, if you may have further distributed this product,
please identify your customers and notify them at once of this
product recall. Your notification to your customers may be
enhanced by induding a copy of this recall notification letter.
This recall should be carried out to the user level. Your
assistance is appreciated and necessary to prevent any
inconvenience."
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
ophthalmic irrigation and aspiration - Product Code KYG
Causa
Plastic shavings are coming from the product
handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
Acción
An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall
Notification Letter are instructions: "In addition, if you may have further distributed this product,
please identify your customers and notify them at once of this
product recall. Your notification to your customers may be
enhanced by induding a copy of this recall notification letter.
This recall should be carried out to the user level. Your
assistance is appreciated and necessary to prevent any
inconvenience."
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
ophthalmic irrigation and aspiration - Product Code KYG
Causa
Plastic shavings are coming from the product
handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
Acción
An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall
Notification Letter are instructions: "In addition, if you may have further distributed this product,
please identify your customers and notify them at once of this
product recall. Your notification to your customers may be
enhanced by induding a copy of this recall notification letter.
This recall should be carried out to the user level. Your
assistance is appreciated and necessary to prevent any
inconvenience."
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
Soft Contact Lenses - Product Code LPL
Causa
Base curve of the lenses do not meet specification.
Acción
Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
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
Neonatal Transilluminator - Product Code HJN
Causa
Excessive heating due to incorrect wire assembly process.
Acción
The firm notified its consignees about the problem beginning on 04/28/2006 and requested the consignee (nurses and distributors) open the battery compartment and check for the absence of an identifying mark (there are no exterior lot numbers). The recalling firm requested the return of all lights which had no identifying marks inside the battery compartment.
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
ophthalmic electrocautery - Product Code NCR
Causa
No documentation to support shelf life/sterility.
Acción
On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.
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, Eye Valve - Product Code KYF
Causa
Product may have deformed valves which would cause the valve not to operate properly.
Acción
Written notification of the recall was sent out beginning 04/12/2006 to hospital administrators to advise them of the recall. The letter stated that implanting physicians were to be notified. A second updated notice was sent dated 04/19/2006 which contained more detailed information regarding the product problem.
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, Eye Valve - Product Code KYF
Causa
Product may have deformed valves which would cause the valve not to operate properly.
Acción
Written notification of the recall was sent out beginning 04/12/2006 to hospital administrators to advise them of the recall. The letter stated that implanting physicians were to be notified. A second updated notice was sent dated 04/19/2006 which contained more detailed information regarding the product problem.