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
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.
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
Eye tray - Product Code OJK
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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
Eye tray - Product Code OJK
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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
Eye tray - Product Code OJK
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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
Refractometer, ophthalmic - Product Code HKO
Causa
Software bug was found where there was no difference in total and corneal high-order aberrations, but differences were found in internal high-order aberrations.
Acción
Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan.
Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.
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
Refractor, manual, non-powered, including phoropter - Product Code HKN
Causa
There has been a reoccurrence of an issue on the rt 5100 and rt 3100 refractor of the near point chart arm lowering spontaneously with potential for slight injury to face or nose of patient.
Acción
Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219.
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, corneal, refractive - Product Code LQE
Causa
Acufocus is recalling kamra aci 7000 corneal inlays due to concerns with the labeled shelf life.
Acción
The firm, AcuFocus, sent an "URGENT FIELD SAFETY NOTICE" letter dated 2/11/16 to all their customers to inform them that AcuFocus is recalling 2 lots of KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The described the product, problem and the actions to be taken. Customers are instructed to report any abnormal appearance of the implanted KAMRA inlay to AcuFocus, inc; stop using and remove from your inventory all affected lots; complete and return the attached Customer Recall Response Form via email: customerservice@acufocus.com, Fax: +1 (949) 585-9545 Attn: Recall Coordinator, or mail to: AcuFocus Inc., Attn: Recall Coordinator, 32 Discovery, Suite 200, Irvine CA 92618, within 3 business days even if you have no inventory affected by this recall; and provide the attached Customer Field Safety Notice and Customer Recall Response Form to your customers who have or may have received product from the affected two lots.
Customers with product complaint events are instructed to report regarding KAMRA inlays involved in this recall event, and to inform AcuFocus, Inc. by calling +1 (949) 585-9511 ext 608. Customers with any questions related to the return process, are instructed to contact an AcuFocus Customer Service Representative at +1 (949) 585-9511 ext 608.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, eye valve - Product Code KYF
Causa
Innovative ophthalmic products (iop) is recalling the molteno 3 g-series glaucoma implant the package insert/instructions for use (ifu) for the device has been updated to add a caution statement to minimize off-label use.
Acción
Innovative Ophthalmic Products, Inc ( IOP ) sent an Customer Notification letter dated February 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken.
The letter informs the customers that IOP is recalling because the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement. Specifically, the new IFU caution statement is "Caution should be taken with supra-Tenon implantation of this device as erosion of the conjunctiva is known to result from the raised edge of the oval pressure ridge."
For further questions please call (202) 857-6464
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.
Alcon is conducting a voluntary medical device correction of all verion reference units (vision planner) that are shared with the alcon lensx laser system after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.Pdf) or exported surgical plans.
Acción
Alcon sent an Urgent Medical Device Correction letter dated February 29, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that an Alcon Technical Services Engineers will contact customers, schedule Service Calls, and perform onsite corrections. For questions call 1-800-862-5266.
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 firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Acción
Ellex Medical Pty Ltd. Planned Action to bring into Compliance:
1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016,
2.All repairs will be made at no cost to the purchaser; and
3.The corrections will be completed by March 30, 2017.
CDRH approves the CAP subject to the following conditions:
Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and
1003.22.
For further questions please call (800) 824-7444.
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
Ophthalmoscope, ac-powered - Product Code HLI
Causa
A software anomaly was detected that affects optovue ivue and ivue 500 with normative database that may display images of the same eye rather than right and left if user scrolls on the map.
Acción
Recall Letters were sent to customers on March 22, 2016 to inform them of the recall.
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
Eye tray - Product Code OJK
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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 discovered that the incorrect lot number was engraved on the product.
Acción
Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should 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.
Notas adicionales en la data
Unit, phacofragmentation - Product Code HQC
Causa
The grounding pin within the power entry switch on certain systems was susceptible to detachment when the ac power cable is removed.
Acción
Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450.
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
Merge received reports of merge eye station being unable to capture images of the eye as expected per the intended use of the product.
merge is recalling product from the field to reduce the risk to patient health.
Acción
Merge sent an Urgent Medical Device Recall letter on December 9, 2016.
The letter was addressed to Office Manager . The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested customers to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to recall@merge.com.
E-mails to be sent to consignees on 12/19/2016. For further questions, please call (262) 367- 0700.
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
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user.
Acción
Consignees were sent on 12/9/2016 a Merge "Urgent Medical Device Recall" letter. The letter was addressed to Office Manager and Recall # 216-078. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested consignees to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to recall@merge.com.
E-mails to be sent to consignees on 12/19/2016.
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
Ophthalmoscope, ac-powered - Product Code HLI
Causa
Fda determined that a 510(k) is needed for the vault mapping software (also known as lens fitting).
Acción
Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.
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
Fda determined that a 510(k) is needed for the vault mapping software (also known as lens fitting).
Acción
Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.
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
Ophthalmoscope, ac-powered - Product Code HLI
Causa
Fda determined that a 510(k) is needed for the vault mapping software (also known as lens fitting).
Acción
Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Unit, phacofragmentation - Product Code HQC
Causa
Alcon is conducting this voluntary medical device recall for a specific lot (2060953h) of its 25+ totalplus vitrectomy pak due a potential that a 23ga ultravit probe may be included within the 25+ totalplus vitrectomy pak, instead of a 25+ ultravit probe.
Acción
Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018.
For further questions please call (713) 668-9100.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Unit, phacofragmentation - Product Code HQC
Causa
Alcon is conducting this voluntary medical device recall for a specific lot (2060953h) of its 25+ totalplus vitrectomy pak due a potential that a 23ga ultravit probe may be included within the 25+ totalplus vitrectomy pak, instead of a 25+ ultravit probe.
Acción
Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018.
For further questions please call (713) 668-9100.
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
Refractometer, ophthalmic - Product Code HKO
Causa
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ark-1s.
Acción
Customers were notified via letter on about 12/20/2017. The letter instructed consignees that a representative from Marco Ophthalmic, Inc. will make arrangements for the affected unit to be picked up and replaced with an ARK-S unit that meets factory specifications.
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
Refractor, manual, non-powered, including phoropter - Product Code HKN
Causa
Product has been found with a missing washer, retaining ring, and/or stop screw. recalling firm was notified by distributor that refractor suspension arm fell on a patient s lower torso along with the arm housing.
Acción
Recalling firm sent letter to customers via certified mail for US customers and via regular mail to foreign customers. Verify product has the presence of the one or more of the three parts: Refractor Suspension Arm missing Screw, Washer and/or Retaining Ring (Snap Ring) that may be missing, and to assure it is functioning properly. For further questions, please call (513) 398-3937