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
Cannula, ophthalmic - Product Code HMX
Causa
One lot may not have been properly sealed, resulting in a non-sterile device.
Acción
Urgent Medical Device Recall letters were sent to all customers on August 6, 2014 by trackable mail. Letters advised on the potential lack of sterility of iTRACK250A, Canaloplasty Microcatheter Kit, lot 1404-03 due to improperly sealed pouches. Lack of sterility may pose the risk of infection to the patient. Customers are identify and segregate any affected product in their inventory. The affected product should be returned following the instructions provided. Replacement product will be provided at no charge. Questions should be directed to Customer Care at 1-888-846-4724, M-F 8 am to 4:30 Pm Eastern Time.
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 LYL
Causa
Out of specification results for one of the two disinfectants.
Acción
Consignees were notified via registered mail starting 04/21/2014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Sponge, ophthalmic - Product Code HOZ
Causa
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Acción
DeRoyal Industries sent an Urgent Voluntary Recall letter dated August 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease usage and return the product to:
DeRoyal Recalls
RA#: Eye Spears
1755 Hwy 33 South
New Tazewell, TN 37825
Ship via UPS Ground using Shipper #312780
Distributors were requested to notify their consignees of the same. The recall is extended to the user level. Customers with questions were instructed to call 1-800-251-9864.
For questions regarding this recall call 865-362-2334.
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
The firm initiated this recall of one lot (121402) of nanopoint injectors after they noticed that tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.
Acción
Medicel AG sent recall notification to its one direct consignee via email on 08/05/2013. The recall notification letter was titled "URGENT-Medical Device Correction Notice for nanoPOINT Injectors LOT 121402". The recall notification letter informed the customer of the product device description and lot number recalled, reason for recall, instructions to "not use this affected lot...and return them", contact information and an area on the bottom of the letter to acknowledge receipt of the correction notice.
The firm's direct consignee who further distributed this product to the end users will send out notifications.
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
Camera, ophthalmic, ac-powered - Product Code HKI
Causa
Under certain circumstances, the left eye image may be saved as the right eye image.
Acción
"Medical Device Correction Notification" letters dated August 5, 2013 were sent to consignees through their US contracted distributor - Marco Opthalmic. The letter described the product issue and provided information on the correction. Customers can contact 800-223-9044 for questions.
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
Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
Causa
Alcon is conducting a medical device removal for the constellation pneumatic handpiece, dsp, product number 725.01. this action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the directions for use.
Acción
Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.
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
Laser, ophthalmic - Product Code HQF
Causa
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. this could potentially cause the video monitor to shut off.
Acción
A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue.
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 recalled the device after learning of a possible deviation in the stimulus luminance of the perimeter octopus 101.
Acción
The firm, HAAG-STREIT USA, Inc., sent a "Field Safety Notice 2012-01/01" dated August 10, 2012 via certified mail or onsite visit to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make all users of the product and relevant personnel aware of this Field Safety Notice; forward a copy to third parties, if affected product has been passed on; keep this notice at least until the completion of the corrective measure, and complete and return the enclosed Confirmation of Receipt Form via fax to: 513-229-3867 or scanned and emailed to : fieldsafetynotice@haag-streit-usa.com.
If you have any questions, call 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.
Notas adicionales en la data
Intraocular lens - Product Code HQL
Causa
The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
Acción
Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference.
In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings.
For further questions please call (909) 937-1033 ext. 108.
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
The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
Acción
Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference.
In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings.
For further questions please call (909) 937-1033 ext. 108.
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
The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
Acción
Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference.
In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings.
For further questions please call (909) 937-1033 ext. 108.
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
The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
Acción
Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference.
In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings.
For further questions please call (909) 937-1033 ext. 108.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Keratome, Ac-Powered - Product Code HNO
Causa
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Acción
Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mislabeling. the incorrect lot number was engraved on the anodized aluminum ring. the correct lot number is be03356; however, bd03356 was engraved on the ring in error.
Acción
Volk Optical sent a Medical Device Recall letter on March 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product. If product was further distributed customers need to identify their customers and notify them at once. Customers were instructed to return the affected device for replacement. Customers with questions were instructed to contact Volk at 440-942-6161 or toll free at 800-345-8655. For questions regarding this recall call 440-510-0745.
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.
Mislabeling. the incorrect lot number was engraved on the anodized aluminum ring.
Acción
Volk Optical, Inc, sent an Urgent Medical Device Recall letter dated March 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The Firm requests that you return the device(s) for replacement, at our cost. The recalled device(s) should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Please contact Volk as soon as you receive this notification to setup a RMA for your device(s).
Please contact Volk at (440) 942-6161 or toll-free at (800) 345-8655 to speak with a Volk RMA Coordinator. To return a recalled device(s) to Volk, please ask Volks RMA Coordinator for the appropriate Volk shipping account number (e.g., FedEx, UPS, etc.).
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 femtosecond laser - Product Code OOE
Causa
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Acción
Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.
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
Cannula, ophthalmic - Product Code HMX
Causa
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Acción
Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.
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 femtosecond laser - Product Code OOE
Causa
Software anomaly on optimedica catalys system version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
Acción
Abbott sent an Advisory Notice dated March 5, 2015, vis Fed Ex overnight to all affected customers. Out of State accounts will be notified through their distributor after letters are translated into local language.
Recall notification letters advise customers of issue with CATALYS System using software version 3.00.05. The letter actually covers two issues, the cataract templates being the same for both eyes, and a loss of suction during treatment that may result in scoring the cornea.
In both cases the issue is explained and users are advised to use mitigation listed to prevent injury. AMO is developing an update to software that will correct these issues and users will be advised when it is available for installation.
All users of the device should be made aware of the issues and each surgeon is requested to sign the acknowledgement form to verify their receipt and understanding. The acknowledgement for should be returned to Abbott Medical Optics per instructions. Questions in the US may be directed to AMO Technical support at 1-855-662-0911.
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
Probe, lachrymal - Product Code HNL
Causa
Expiration date incorrectly printed in manufacturing date field on both pouch and carton labels.
Acción
The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.
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
Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla - Product Code LXS
Causa
Dear doctor letter and quick reference guide is being sent to users of the yc-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images.
Acción
Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February.
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
Aaren scientific is recalling intraocular lenses because the instructions for use (ifu) are not fully compliant with us requirements.
Acción
A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at mark.scheib@zeiss.com with any questions or comments.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Keratome, ac-powered - Product Code HNO
Causa
The ml 7090 calibrated lasik blade (clb) will not fit into the amo amadeus metal blade holder.
Acción
The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the 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
Laser, ophthalmic - Product Code HQF
Causa
The spot size control of the scan delivery unit of the mc-500 multicolor laser photocoagulator may turn by itself.
Acción
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
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
Plug, punctum - Product Code LZU
Causa
Moisture level may cause the visiplugst (or collasyn plugs) to break apart, or crumble upon contact. the firm's data also suggests that a 4 year shelf
life may not be sustained.
Acción
The firm notified their foreign consignees on 11/26/14. The firm made a decision to conduct a domestic recall on 12/4/14 and will notify US consignees
Consignees will be provided with a return label and request any devices that they still have be returned to the firm.
Any consignees that have gone out of business will be sent a certified letter to their last known address.
CORRECTIVE ACTIONS:
The firm has halted sales of the device until the drying method can be improved. Any remaining stock has been placed in quarantine and will be scrapped.