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 lenses - Product Code LPL
Causa
Out of specification lens curve.
Acción
Consignees were notified via traceable mail on 09/13/2006.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
Lens, Contact, (Disposable) - Product Code MVN
Causa
Identified lots of proclear compatible contact lenses are counterfeit and may not be sterile.
Acción
Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.
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.
Routine testing indicates product does not meet the expiration date in all cases.
Acción
Product is being recalled due to concern that the product does not meet it's expiration date. Firm sent letters to it customers requesting them to remove product from stores and to destroy it. A destruction form was sent with a request to mail it back.
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
Blade may become detached from the handle.
Acción
BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall 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.
Notas adicionales en la data
Lens, contact, (disposable) - Product Code MVN
Causa
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Acción
On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
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.
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Acción
On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
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.
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Acción
On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
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 identified a labeling error affecting made-to-order
(mto) biofinity xr toric blister labels. the primary blister reads biofinity multifocal toric in error, and should read biofinity xr toric. the outer carton correctly reads biofinity xr toric.
Acción
Notifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273.
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 recommended storage temperature on the label is incorrect.
Acción
Aaren Scientific sent an Urgent Medical Device Recall letter dated August 31, 2017. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1.Compare your inventory against the above list.
2. STOP using and REMOVE from your inventory all affected Z28 listed above. 3. Complete and return the attached Customer Reply Form EVEN IF YOU HAVE NO INVENTORY affected by this recall, to Aaren Scientific, Inc. Quality Management at (909) 937-1033 or email to Z28recall.med.us@ZEISS.com within 3 business days of receipt of this letter. Upon notification, Aaren Scientific, Inc. will supply you with a Return Good Authorization Number to replace all remaining customer inventory of the affected product immediately. Aaren Scientific, Inc. requires this information for reconciliation purposes with regulatory agencies. No other Aaren Scientific, Inc. Z28 Cartridges are affected by this action. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have inventory of any of the Z28 Cartridges with the batch numbers listed, please contact Customer Support at (909) 937-1033 to arrange pick up of lenses to be returned.
Page 2 of 4
If you have product complaints or adverse events to report regarding the use of the Z28 cartridge, please inform Aaren Scientific, Inc. by calling. When reporting a complaint, please provide the Z28 cartridge batch number and, if a patient was involved, the date of surgery, a description of the event and patient
outcome.
For questions regarding this recall call 909-906-5119.
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.
According to firm ( bausch & lomb, inc. ) on june 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of sku 0816 c (pterygium burr medium diamond).
further investigation found that repackaged algerbrush-ii and its accessories from april 30, 2012 to present, contained out of date operating instruction. therefore bausch & lomb is proposing a field correction to provide customer purchasing product from april 30, 2012 to june 20, 2016 with the current operating instruction.
Acción
Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020
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.
Product was found to contain excess residual levels of hydrogen peroxide.
Acción
The firm, Bausch & Lomb, sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated 9/29/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter: review your inventory including floor displays; contact Stericycle, the firm conducting the product recall on behalf of Bausch & Lomb, to arrange for return of the product; and complete and return the Recall Acknowledgement Form to Stericycle Inc,, even if you do not have any of the product in your inventory, via Fax to 1-877-779-7814, email: BauschandLomb5833@Stericycle.com or phone: 1-877-877-0481.
If you have any questions about this voluntary recall process or would like additional information, please contact Stericycle, Inc., the firm conducting the recall on behalf of Bausch & Lomb at 1-877-877-0481.
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
Eyelid thermal pulsation system - Product Code ORZ
Causa
Complaints related to an error condition occurring during patient treatment where the fipiflow system automatically stopped treatment after detecting a problem with the activator.
Acción
The firm, TearScience, sent a "Medical Device Recall" letter dated September 9, 2016 to its consignees/customers on 9/13/2016. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email to: Customerservice@tearscience.com or mail to TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement.
For any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.