Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Radiometer medical has become aware that lot r0530 of 942-073, d8088-crea a,d8089-crea b, membrane box for e8088 and e8089 electrodes has been packed in error with capsules of electrolyte solutions for glucose/lactate electrodes. testing by the manufacturer has established that the incorrect capsules of electrolyte solutions do not influence the performance of the crea results.
Acción
Radiometer is requesting their customers to discard remaining units from the affected lots. Alternative units are available. This action has been closed-out on 01/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed the advia centaur systems cleaning solution, lots 459356 and 443105, has degraded at a higher than expected rate. siemens have confirmed that there is sufficient concentration of sodium hypochlorite to ensure effective instrument cleaning at this time.
Acción
Siemens is advising their customers to discontinue use of and discard the affected kit lots. This action has been closed-out on 26/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
During an internal investigation, the manufacturer determined that well number 3 of id card nacl, enzyme test and cold agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-e (anti-rh3).
Acción
Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results:
- By manual method, do not use well 3 of the card.
- On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An unexpected assay calibration may occur when using calibrator barcode labels supplied with vitros chemistry products calibrator kits for assay targets that are unassigned.
Acción
A correction for this issue will be included in the next version of the software. Ortho-Clinical Diagnostics is requesting their customers to not use the calibrator barcode labels for VITROS Calibrator Kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on the VITROS System. This action has been closed-out on 25/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The information referenced in the current ifu is incorrect with regards to specimen stability for samples in stoppered tubes. in the instruction for use (ifu), the paragraph “specimen stability” states, “the stability of the sample separated from the clot has been validated using samples in stoppered tubes: at 18-25°c for 3 days”. further review identified that the data of the stability study mentioned in the product review development report file (ref. vr11) is “for stoppered tubes, at 18-25°c for 8 hours”. the instructions for use should state: “the stability of the sample separated from the clot has been validated using samples in stoppered tubes at 18-25°c for 8 hours”.
Acción
BioMerieux is notifying their customers that the IFU incorrectly states that sample is stable for 3 days at 18-25 degrees C once separated from the clot. The correct stability is 18-25 degrees C for 8 hours. This action has been closed-out on 01/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Tag medical have been advised by aerogen ltd that there is a potential hazard with certain friwo power adaptors as supplied with the aerogen pro and aerogen solo nebuliser systems manufactured during the period of week 50/2013 and week 23/2014. the power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open.
Acción
Tag Medical is contacting the hospitals and replacing the faulty FRIWO power adaptors free of charge. This action has been closed-out on 06/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the advia centaur systems hbc total (hbct). the increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.The increase in the number of false reactive results may cause additional testing but should not result in the reporting of an increased number of false positive results to physicians. the instructions for use (ifu) recommends that clinical interpretation be made in conjunction with other hbv serological markers.
Acción
Siemens is asking customers to discontinue use and discard the affected kit lots. Customers are advised to review the letter with their Medical Director. This action has been closed-out on 18/04/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus). this may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. the tubing disconnection or leakage may also increase the risk of ventriculitis. if undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death. these systems are most often used on neurocritical care floors and these issues are likely to be detected immediately.
Acción
Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place.
STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim.
STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product.
In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection.
After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM.
This action has been closed-out on 28/02/2018,
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Grifols australia wishes to advise of an error identified on the antigen composition sheet for perfect panel.The antigen composition sheet supplied with the affected lots of product states cell no. 6 as donor no.154. the antigen composition sheet should state cell no. 6 as donor no. 213 and the corresponding phenotypic profile.
Acción
Grifols Australia is providing their customers with the correct Antigen Composition Sheet with the recall action correspondence. This action has been closed-out on 06/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Abbott molecular has identified that when duplicate sample ids are used for multiple replicates of a sample, calibrator or control in the same run: some samples may not be included in the plate report; some duplicate sample ids are reassigned a unique identifier by the software and a warning message is displayed in the plate report. these issues occur if duplicate sample ids are used within a run, on the m24sp plate report. the m24sp plate report is a pdf file generated by the software for each instrument run. it provides a list of sample id’s and their processing information and error status.
Acción
Abbott Molecular is advising users that to ensure proper function of the Plate Report, duplicate sample IDs should not be used on the m24sp. If two or more replicates of a sample, calibrator or control are being run, a unique sample ID should be used for each of the replicates. This action has been closed-out on 15/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This is an update to the august 2013 physician communication (tga ref.: rc-2013-rn-00906-1). the performance of an lv capacitor may be compromised in some devices after two or more years of implant time, which will increase battery use and may eventually initiate one or more safety architecture alerts and patient-audible beeping. the most common alert is a yellow programmer screen that states, “voltage is too low for projected remaining capacity. contact technical services with code 1003”. latitude issues a corresponding yellow alert (nominally configured “on”). in other instances, diminished lv capacitor performance can result in an early “explant” battery status indicator (eri) and a replacement window that may be less than 3 months. boston scientific has identified a second subset of devices that may exhibit a similar issue. no patient deaths have been associated with this issue. affected devices have not been available for implant for more than three years.
Acción
Boston Scientific has recently introduced updated software that will further improve Safety Architecture effectiveness. Boston scientific recommend that patients with a device in the affected population be scheduled for an in-clinic visit to upgrade their device with this new software. After a device has been upgraded, continue normal device monitoring as directed within labelling, and promptly investigate all alerts and device beeping.
Devices that experience a low voltage alert require replacement. If not replaced, increased current drain could deplete the battery and impact therapy delivery and telemetry. If a Safety Architecture alert is observed, Boston Scientific Technical Services can analyse device information downloaded from a recent in-clinic or LATITUDE interrogation, which will clarify approximately how much time is available to replace the device.
Fro more details, please see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130924.htm . This action has been closed-out on 07/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Alcon are discontinuing the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ecl). in the clinical study, patients’ endothelial cell density (ecd) levels are monitored at 6 month intervals, as recommended by the current cachet phakic lens directions for use (dfu). to date, only 2.7% of the 1,323 cachet phakic lenses implanted in the clinical study were explanted due to ecl.
Acción
If you have inventory of the CACHET Phakic Lens, these lenses can be returned to Alcon for reimbursement. Patients with the CACHET Phakic Lenses already implanted, Alcon is recommending opthamologists adhere to the monitoring requirements described in the current DFU. Adherence to these requirements will help to timely identify significant ECL and determine the appropriate treatment plan. For more details, please see http://www.tga.gov.au/safety/alerts-device-acrysof-cachet-phakic-lens-140924.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Biomerieux have identified the product may contain low level contamination in some plates. contaminants were identified as (1) bacillus cereus, (2) hafniaalvei, and (3) staphylococcus epidermidis.
Acción
bioMérieux requested the customers to inspect the above product prior to use and discard any
plates found to be contaminated. Complimentary replacement stock has been shipped in the same quantity as originally provided.
This action was undertaken prior to approval of the recall strategy by the TGA.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens has identified that immulite/immulite 1000 cortisol kit demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. the positive bias was also observed in quality control materials and may result in values outside the established ranges.. the observed positive bias in cortisol values may potentially lead to additional investigation of adrenal status.
Acción
Siemens are advising users to discontinue use and discard any remaining kits. The issue has been resolved with IMMULITE/IMMULITE 1000 Cortisol kit lots 384 and above (supplied since 1 August, 2014). A look back of previously generated results is at the discretion of laboratory. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Zimmer has received complaints related to binding of the distal valgus alignment guide's locking knob. persona distal valgus alignment guide collet locks are seizing in the 'unlocked' position during normal operation. this seizure causes the diameter between the collet pegs to become smaller than that of the 8mm im (intramedullary) rod and prevents the rod from being inserted or removed from the alignment guide rendering the device unusable. the root cause of the binding was determined to be excessive counter-clockwise rotation of the knob when unlocking the device.
Acción
Zimmer determined that additional guidance on the locking/unlocking feature was needed. Zimmer is requesting the customers to review the updated portion of the Persona surgical technique (97-5026-001-00) provided with the customer letter, which details use of the Adjustable Valgus Guide. This action has been closed-out on 07/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Continuous use of the ip5 for more than 24 days, without power cycling, results in a graphical user interface (display screen) error, which causes the numeric data on the display to freeze and disables some menu keys. waveform data displayed and audible alarms are not impacted by this problem and continue to function properly. this could result in delay in treatment of the patient caused by the displayed numeric value not correlating with the patient's status.This is an update to the previous recall for product correction (tga ref.: rc-2014-rn-00349-1) which informed end users to ensure that the ip5 should be power cycled every 24 hours to prevent the above issue from occurring. now a permanent software solution is available.
Acción
A Philips representative will contact the customers and all affected devices will have a software update installed in order to address the problem. After the software update is installed, if the device is allowed to run for an extended period of time, the device will begin to notify users of the need to power cycle the device using various degrees of warning “restart required” prompts (dialog boxes). If the device is not power cycled when this time expires, the device will power down and sound a tone to inform users of the action. Until the software solution is implemented, users should ensure that the IP5 is power cycled once every day. This action has been closed-out on 5/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens has confirmed that the dimension hb1c flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] haemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).
Acción
Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred:
- HbA1c testing was performed on your patient(s) using the affected lot numbers
- There may have been adjustments in therapy based solely on the HbA1c value(s),
- There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Zimmer has received complaints related to the fracture of persona tibial articular surface provisional (tasp) tops and bottoms. based on the investigation results of these complaints, zimmer determined that updates to device labelling associated with the zimmer persona knee system were required to provide additional clarifications relating to the instructions for use of the tasp construct. .
Acción
Zimmer is advisingthat the updated technique for use of the TASP construct and its components can be found on pp. 34-37 of the Persona Surgical Technique (97-5026-001-00, Rev. 8) which includes:
• Apply gentle manual pressure without impacting the TASP construct with either a mallet or hand. The TASP construct includes the TASP top, bottom, shim, and Tibial Sizing Plate Handle.
• During assembly of the TASP construct, slide the shim in using a direct anterior approach between the TASP top and bottom. To avoid inadvertent separation, maintain slight pressure between the TASP top and bottom while inserting the shim.
• Varus/Valgus forces may make it difficult to remove the TASP construct. To aid in the removal of the TASP and prevent breakage, ensure that the joint is in a neutral position when removing the TASP construct. This action has been closed-out on 18/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Covidien has received two reports where customers attempted to use a covidien electrode with a philips fr3 aed unit. these electrodes will not connect with philips fr3 or frx aed units, and in the case of the use of covidien defibrillation electrodes with the philips fr3 aed units, could result in a delay of therapy. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use.
Acción
Covidien is modifying the labelling to clarify that use of the affected electrodes are incompatible with certain AED units. This action has been closed-out on 18/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens has identified a potential problem with the artis zee and artis zeego systems with the a100 generator and specific lots of a 3 focal spot x-ray tube. the “small focus” of a 3 focal spot x-ray tube may sporadically fail if the case grounding detaches from the focus head and overheating occurs. further radiation release won’t be possible. an ongoing procedure can be continued by using one of the two remaining focal spots ("large focus” or "micro focus") instead. to achieve that, the operator will need to switch over to the other focus, thus causing a short interruption of the ongoing procedure.
Acción
Siemens is implementing a software update that will protect the affected component from any damage in case the grounding detaches from the focus head. In case of such a potential failure, the system will automatically switch to the "Large Focus”. This action has been closed-out on 07/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Pfizer is recalling dimetapp saline nasal drops for infants following a complaint received by tga. the nature of the complaint involved the nozzle of the product becoming dislodged and subsequent flowing of the saline fluid onto a baby’s face.
Acción
Retailers and wholesalers are requested to inspect their stock and quarantine all units from the affected batches (21320 and 21465). Retailers are also requested to retain any units returned by consumers and provide a refund or replacement. This action has been closed-out on 18/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has received a report from the field of incorrect product information identified in trident surgical protocol (lsp69) and trident product reference guide (lx3prg). lsp69 and lx3prg each contain a table which references an incorrect number of screw holes for trident hemispherical ha cluster shell sizes 44mm – 50mm.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user and therefore there is a potential risk of electrical shock.
Acción
Covidien is contacting the hospitals and will ship replacement adapters free of charge. Covidien is further requesting the customers to destroy the affected adapters per local disposal processes, when replacement AC mains power adapters are received. This action has been closed-out on 06/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Coopervision's investigation of complaints have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. there is not likely to be added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance.
Acción
Retailers (practitioners) are advised to stop any further patient order fulfilment of the affected lots of Proclear Toric lenses and quarantine them for returning it to Coopervision. Patients will be provided full refund for any affected product returned by them. This action has been closed-out on 17/05/2017.