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.
Medtronic is removing specific lots of the ascenda intrathecal catheters and revision kits, which are used with the implantable synchromed drug infusion pump. this recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. there is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne.
Acción
Medtronic sent an Urgent Medical Device Removal letter dated July 11, 2014, to all affected customers. The letter described the issue, identified affected product, provided patient management recommendations for patients implanted with an affected device, asked for Risk Management to quaratine unused inventory within the hospital, and to contact Medtronic Customer Service at 1-888-638-7627 to facilitate return of 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.
Inability to calibrate or use vitros nh3 dt slides, gen 59 with vitros chemistry products dt calibrator kit, lot 44 when cdm prom 0168 or 0169 is installed on vitros dt60/dt60 ii chemistry systems.
Acción
Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44.
Customers were instructed to forward this notice if the product was further distributed outside of their facility.
OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59.
Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311.
For questions regarding this recall call 908-218-8776.
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.
Baxter healthcare corporation is voluntarily issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. affected product codes are: 2c7564, 2c8864 and 2h8864.
Acción
Action to be taken if product was purchased directly from Baxter:
Baxter is requesting that you take the following actions:
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.
3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail.
4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014.
Action to be taken if the products were purshased from a distributor or re-seller.
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling.
3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
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.
Baxter healthcare corporation is voluntarily issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. affected product codes are: 2c7564, 2c8864 and 2h8864.
Acción
Action to be taken if product was purchased directly from Baxter:
Baxter is requesting that you take the following actions:
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.
3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail.
4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014.
Action to be taken if the products were purshased from a distributor or re-seller.
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling.
3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory 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 recall data from the U.S. and the United Kingdom.
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.
Baxter healthcare corporation is voluntarily issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. affected product codes are: 2c7564, 2c8864 and 2h8864.
Acción
Action to be taken if product was purchased directly from Baxter:
Baxter is requesting that you take the following actions:
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.
3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail.
4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014.
Action to be taken if the products were purshased from a distributor or re-seller.
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling.
3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
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
Film, radiographic - Product Code IWZ
Causa
Some sheets of the medical screen film are fogged.
Acción
On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). The letter described the safety alert and the request to quarantine affected product. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so that it could be sent to their 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.
The tube fastener on the et tube holder may compress the tracheal tube when used which may cause difficulty when locking the et tube holder in place or difficulty when passing a
suction catheter.
Acción
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com.
Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361.
For questions regarading this recall call 866-216-8806.
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.
Brainlab navigation software spine & trauma 3d 2.0/2.1 offers automatic registration of intraoperatively acquired ct image data sets. to enable automatic registration, the software requires the gantry position of the scanner.
the gantry position can either be entered manually or submitted automatically from the ct scanner. if automatic gantry communication is available, the so-called ".
Acción
The firm, Brainlab AG, sent "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letters dated May 21, 2014 to all consignees. The letters included instructions for consignees to: 1) not use Automatic Registration of iCT Data in combination with Siemens SOMATOM Definition AS CT scan (with Software Somaris SOM 7 or higher and Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only); 2) always make sure to perform careful accuracy verification according to the instructions in the Software User Guide; 3) Brainlab will perform corresponding service visits to change the gantry communication from automatic to manual to enable a safe and effective usage of this device combination, and 4) advise the appropriate personnel working in your department of the content of the letter.
Customers with any questions can contact Brainlab via telephone at 800-597-5911 or e-mail at us.support@brainlab.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.
The tube fastener on the et tube holder may compress the tracheal tube when used which may cause difficulty when locking the et tube holder in place or difficulty when passing a
suction catheter.
Acción
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com.
Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361.
For questions regarading this recall call 866-216-8806.
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 tube fastener on the et tube holder may compress the tracheal tube when used which may cause difficulty when locking the et tube holder in place or difficulty when passing a
suction catheter.
Acción
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com.
Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361.
For questions regarading this recall call 866-216-8806.
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 tube fastener on the et tube holder may compress the tracheal tube when used which may cause difficulty when locking the et tube holder in place or difficulty when passing a
suction catheter.
Acción
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com.
Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361.
For questions regarading this recall call 866-216-8806.
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
Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
Causa
Zimmer is initiating a voluntary recall of 20 production lots of moore hip prosthesis long fenestrated stems due to packaging design verification test failures. specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the moore hip stem breached either the inner or outer package tray. zimmer has not received any complaints of damaged package trays for these 20 lot.
Acción
On July 1, 2014 Zimmer, Inc. issued recall notification to their consignees via letter. This notice was issued to affected distributors and hospitals with instructions for returning the affected product. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product and providing related contact information (name, address, and phone number). Distributors are to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative.
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 tube fastener on the et tube holder may compress the tracheal tube when used which may cause difficulty when locking the et tube holder in place or difficulty when passing a
suction catheter.
Acción
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com.
Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361.
For questions regarading this recall call 866-216-8806.
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
Accelerator, linear, medical - Product Code IYE
Causa
While the proteus 235 is in the pencil beam scanning (pbs) treatment mode, on rare occasions, low level radio frequency (llrf) pulsed dee voltage (i.E., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Acción
A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory 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 recall data from the U.S. and the United Kingdom.
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.
Siemens healthcare diagnostics has received complaints for the dimension chemistry wash (rd701) of qc and patient sample result accuracy shifts on troponin i, ctni (rf421c), ltni (rf521c); free t4, ft4 (rf410); thyroid stimulating hormone, tsh (rf412); and n-terminal pro-brain natriuretic peptide, pbnp (rf423a) and lpbn (rf523a) when using dimension® chemistry wash lot rd41041.
internal inv.
Acción
Siemens sent an Urgent Medical Device Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions to be taken by the Customer:
1. Immediately discontinue use and discard all inventory of Chemistry Wash lot
RD41041.
If this lot was never in use on the instrument, no further action is needed.
If this lot has been in use, continue with steps 2 through 5.
2. Place an alternate lot of Chemistry Wash on the Dimension system.
3. Prime the new bottle of Chemistry Wash 30 times.
4. Recalibrate the CTNI, LTNI, TSH, FT4, PBNP and/or LPBN assays using the alternate lot of Chemistry Wash on board.
5. For the listed assays, process Quality Control every 8 hours.
Actions to be taken by Siemens:
Your Customer Service Engineer will be making a visit to decontaminate the system if you have used lot RD41041. This process will take approximately two hours. Once decontamination has been completed, process and evaluate quality control. Resume routine QC testing frequency according to your standard laboratory practice.
Siemens is shipping replacement product at no charge for all orders filled with lot RD41041. If you have questions about your replacement shipment, please contact Customer Service at (888) 588-3916.
Please complete the attached form and fax it to (302) 631-8467 to indicate that you have received this information.
Please retain this letter with your laboratory records. Please forward this letter to anyone to whom you may have provided this product.
We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The reagent lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Acción
Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
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
intraocular lens - Product Code HQL
Causa
Units may be labeled with the incorrect diopter power.
Acción
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions:
1. Stop using and remove from your inventory the affected product.
2.Complete and return the included Facsimile Form as AMO.
If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.