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
Folders and injectors, intraocular lens (iol) - Product Code MSS
Causa
The intraocular lens could become lodged within the cartridge.
Acción
Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon.
For questions regarding this recall call 817-551-3058.
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
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the infiniti ultrasound packs.
Acción
The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
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.
Iol master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong iol power data.
Acción
Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations.
All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
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.
Iol master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong iol power data.
Acción
Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations.
All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
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 firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. complaints of halo or poor visual acuity.
Acción
On 9/3/2015, the distributors received the Medical Device Recall Letter (dated 9/2/2015) via e-mail. Medical Device Recall Letters (dated 9/2/2015) and Customer Acknowledgement Cards were hand delivered to the direct customers via Bausch + Lomb Sales Representatives starting on 9/14/2015 or sent via FedEx if consignee is not a B+L account. The letter informs the accounts of the recall and instructs them to direct any consumers who would like to report a product complaint, arrange for a product exchange, or obtain more information on the product recall to contact the Bausch + Lombs Consumer Affairs Team at 1-800-553-5340 or via e-mail at BLCustomerCare@bausch.com. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected 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
Excimer laser system - Product Code LZS
Causa
The failure to comply with minimum system requirements, increased system errors could result, and a miscreated treatment table (incorrect lasik refractive treatment) could result.
Acción
Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were asked to take the following actions:
Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530.
For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com.
For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.
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
Implant, Eye Sphere - Product Code HPZ
Causa
Integrated orbital implants, inc. has initiated a recall of it's sterile bio-eye hydroxyapatite orbital implant and conformer due to a labeling issue in which the expiration date of the product was omitted.
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
Product did not have proper 510(k) clearance.
Acción
A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.
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
Ocular Surgery Irrigation Device - Product Code KYG
Causa
Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
Acción
All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return 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
Ocular Surgery Irrigation Device - Product Code KYG
Causa
Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
Acción
All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return 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.
The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. lnad made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.
Acción
Luxottica Optical Manufacturing sent notification letters on June 30, 2010, to their customers informing them of the problem.
Customers were instructed to complete the enclosed Sport Goggle Return Form, and to indicate whether they would like a replacement pair of goggles or a refund.
Place the completed Sport Goggle Return Form and their sport goggles (without the sport goggle case) in the envelope provided and return it to the firm via the United States Postal Service. Customers were instructed not to return to the retail store where purchased.
If customers were unable to return their sport goggles because they were lost or discarded, customers should complete the appropriate information on the Sport Goggle Return Form, being sure to indicate whether they would like a replacement pair of goggles or a refund, and then sign the form. Place the completed Sport Goggle Return Form in the envelope provided and return it to the firm via the United States Postal Service.
For any questions, call 1-877-488-2407.
They instructed their customers to return the product for replacement or refund.
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.
During the creation of the lenstar ls 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for us distribution. the current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in.
Acción
HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated.
For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255.
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.
Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
Acción
Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed.
For further information, contact Kim's Trading Inc. at 1-484-895-3773.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Acción
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.
Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.
Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:
KC Pharmaceuticals-SALP Recall,
3201 Producer Way,
Pomona, CA 91768.
Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
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.
Software not validated; inaccurate results may occur.
Acción
On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.
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 ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
Acción
A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device.
If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free 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.
The ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
Acción
A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device.
If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free 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
unit, phacofragmentation - Product Code HQC
Causa
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
Acción
The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form.
If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
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
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
Acción
The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form.
If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
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
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
Acción
The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form.
If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.