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
The mrx could contain incorrect internal software settings, causing the following two issues:1. the device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended.2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead, the rfu will show a flashing black hourglass, indicating that sufficient battery power is available for device operation. there is a potential for a delay in therapy due to insufficient battery power.
Acción
Philips is initiating a correction that will consist of replacement of the therapy capacitor and reset of internal software settings. Prior to receiving correction, customers can continue to use the affected MRx provided that they follow workaround steps identified in the customer letter. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behaviour for no/low battery conditions.
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
Tornier have identified that the humeral broaches aequalis can become more fragile over time resulting in breakage during surgery.
Acción
Tornier is requesting hospitals and distributors to return the affected parts. 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
It has been reported that the small electric drive (sed) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device. this may lead to surgical delays in the event the user requires a replacement power tool. an unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and /or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. these injuries may need surgical or medical intervention.
Acción
Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. 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
Some patients have reported experiencing an uncomfortable temperature increase at the ipg implant site during charging, with a small number of patients reporting burns at the implant site. this matter is a follow-up to a hazard alert letter issued by st. jude medical (sjm) in august 2012 (tga reference: rc-2012-rn-00759-3). in the august 2012 letter, st. jude medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. the new eon mini le charging system model 3722 and eon mini le charger model 3720 reduce the potential for uncomfortable temperature increases that may be felt near the ipg while recharging by automatically turning the energy it delivers on and off. this will require patients to charge longer or more frequently to achieve a full charge.
Acción
St. Jude Medical recommends the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow up. Upon replacement, proper charging function of the Eon Mini LE Charger Model 3720 must be confirmed. The Eon Mini LE Charging System Model 3722 and Eon Mini LE Charger 3720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 3721 was labelled for implant depth up to 2.50cm). In case of difficulties with the charging function of the Eon Mini LE Charger Model 3720 due to the depth of the implant, patients should continue to use their current Eon Mini Charging System Model 3721 following the precautions provided in the August 2012 letter. This action has been closed-out on 04/04/2017.
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
Some reagent cartridges (reag cart) of this kit lot contain reagent troughs that are not filled correctly. this leads to decreased quality of the resulting nucleic acids.
Acción
End users are advised to discard any remaining affected lots of QIAsymphony DSP Virus/Pathogen reagent. It is also recommend that results from samples processed on the QIAsymphony using the affected reagent are reviewed. 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
The mrx can be susceptible to one or both of the issues described below:-1.) the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx monitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. a life threatening situation could occur if etco2 is unavailable and the clinician has no other reliable method for determining c02 statusincluding proper intubation without dislodgement.2.) the handle can separate from the mrx housing due to breakage of mounts on the rear case. this is a drop hazard and may potentially cause bodily injury or failure to deliver therapy due to the unit becoming damaged during impact.
Acción
Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.
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
In certain cases an inratio & inratio2 pt/inr monitor system may provide an inr result that is clinically significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions.Br /br /further information has been published on the tga website at - http://www.Tga.Gov.Au/alert/alere-inratio-ptinr-monitor-system .
Acción
Alere is advising consumers and healthcare professionals of the additional warnings and precautions required when using the INRatio & INRatio2 PT/INR Monitor systems. Consumers are requested to consult their doctor to determine if any of the following conditions apply to them:
- Anaemia (haematocrit < 30%)
- chronic inflammatory conditions
- severe infection
- advanced stage cancer or end stage renal disease
- any bleeding or unusual bruising. This action has beenclosed-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
A mismatch between the sample id and the test result reported will occur if the following specific circumstances occur. 1. a barcode reading error 0-1502 occurs (error #1)2. the operator then selects “enter id” in order to manually assign the sample tube a sample id number3. another error message of any kind occurs (error #2) before the sample id is entered (the “enter id” screen remains open on the instrument)4. when more than 5 minutes elapse after “error #2” occurs, but before the “enter id” screen is closed by the operator, a third error (error #3) occurs which requires a response from the operator5. the operator then closes the “enter id” screen by touching either the “rack pass” or “back” buttons on the touch screenthis will result in a mismatch between for all subsequent sample racks in that run.
Acción
Abacus ALS is providing a software update to correct the issue. Until the software update is installed end users are requested to take the following actions:
If a user is presented with a 0-1502 error, BAR CODE ERROR (Sample Rack):
- select “Pass” (i.e., do not select “Enter ID”), or
- do nothing (since the error will be automatically released after more than five minutes).
Any sample with a barcode reading error will then not be processed. It may be processed later in the run after the sample rack has been ejected from the sampling area. This action has been closed-out on 04/04/2017.
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 following problems were found during internal testing:if electrical fast transits (eft) noise is injected into the monitor/defibrillator via ac mains power, and the monitor/defibrillator is connected to and receiving ecg signals from an auxiliary bedside monitor with an m1783a/m5526a 12 pin sync cable (8/24 feet) via the monitor’s ecg out port, then:1. when using a sync cable with the heartstart mrx or heartstart xl, eft noise can be mistaken as an r-wave. if this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to eft noise instead of the patient’s actual r-wave. 2. when using a sync cable with the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. a power cycle is required to resume ecg monitoring, however, fixed mode pacing is not impacted by this issue.
Acción
Philips will replace all affected sync cables with a new sync cable free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for a replacement.
This action has been closed-out on 05/12/2016.
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
Vials manufactured prior to june 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. if an affected vial is used with a patient sample, a significant shift in inr greater than 10% could occur with the potential to alter subsequent medical treatment.
Acción
Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.
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
Incorrect patient positioning at the linac might occur, if all of the following conditions are met:1. at least two different ct datasets are being used and have been both localized and fused toeach other in the same treatment plan.2. the latest ct scan used with the localizer is not assigned as both reference set and alignmentset (for definitions, see the appendix).3. patients are positioned at the linac using one of the following positioning solutions:- target positioner- exactrac v.4.5 or v.5.X- exactrac vero (from v.2.1 up to v.3.2.1)the magnitude of potentially incorrect patient positioning is given by the difference in patient position inside the localizer during the two ct scans, one of which was assigned to the reference set and the other to the alignment set.
Acción
1) Brainlab will provide existing potentially affected iPlan RT / iPlan RT Dose customers with this product notification information.
2) Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update.
3) Brainlab will refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. This action has been closed-out on 22/08/2016.
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
It was reported that both the steel cables in a proteus system wall stand failed and the bucky cabinet (68kg) fell to the floor. the unit was not in use, no patient or operator injury was reported. the proteus wall stand assembly associated with this event was identified as model 600-0301. the steel cable used with this wall stand is 603-3220. an investigation concluded that the root cause was fatigue of the braided rope.
Acción
1. GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact customers to arrange for this correction.
2. To prevent occurrence of these issues in the future, the Service Procedures including the service interval for periodic cable maintenance and replacement is also being updated.
The updated Service Procedure (2273022-100 Rev 31) will be available by 15th Jan 2015 at a website link that is to be provided in the Customer Letter. This ation has been closed-out on 11/08/2016.
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
A cable inside the c-arm of systems affected may have been routed in an inappropriate manner and there is a potential that with increased wear a cable inside the c-arm may break. a cable break will result in restricted functionality and even system failure.
Acción
Siemens is replacing the affected cable harness with a modified version in addition to re-routing the cables to prevent wear. 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
In the event the affected drill is presented for use; the drill could break or overheat and potentially lead to a surgical delay.
Acción
Smith & Nephew is requesting their customers to inspect their inventory for devices with the affected Model and batch numbers and quarantine them immediately. A Smith & Nephew customer service representative will for a arrange collection of any affected products. This action has been closed-out on 26/08/2016.
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
Radiometer has recently become aware of a potential risk of receiving a false high result when using the aqt90 flex tni test kit, 942-903, lot 09619. it has been reported that calibration adjustment cups may have been packed into the tni test kit cartridges of this lot. thus, in some test cartridges, one or more cups may be a calibration adjustment cup instead of a test cup.Patients receiving the erroneous result may be diagnosed as having an acute myocardial infarction and may immediately be subjected to standard treatment for this disease (such as surgical intervention percutaneous transluminal coronary angioplasty or treatment with fibrinolytic or other drugs). subsequent normal measurements of tni should result in recognition of the erroneous diagnosis and termination of the wrongful treatment.
Acción
Radiometer are advising their customers to:
1. Check inventory and remove all AQT90 FLEX TnI Test Kit Boxes of the affected lot 09619;
2. Discard all affected stock; and
3. Review any patient results, in conjunction with the Medical Director, where affected test kits are known to have been used.
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 manufacturer, mathys ltd bettlach, received reports of disconnection of affinis inverse inlay ceramys and affinis fracture ceramic heads. subsequent investigations have identified that the inlay and individual implant components complied with the defined specifications.For affinis fracture ceramic heads:the disconnections may have resulted from inadequate primary fixation due to insufficient head-cone connection or by protruding bone residue, cement residue or soft tissue fragments inside the cone connection.For affinis inverse inlay ceramys: the disconnection incident was caused by insufficient fixation of the inlay on the cone due to lack of impaction. the affinis inverse inlay ceramys has not been supplied in australia.To minimise occurrences of disconnection, additional instructions and notes regarding ceramic inlay implantation and ceramic head implantation have been added to the surgical technique and the instructions for use (ifu).
Acción
Mathys Ltd Bettlach is requesting the customers to replace all Surgical Techniques and Instructions for Use (IFUs) for Affinis Inverse and/or Affinis Fracture with the updated versions provided. The sponsor has directly contacted the surgeon to notify of the implications of inadequate fixation and to provide the updated instructions.
Further information will be published on the TGA web site at http://www.tga.gov.au/current-year-alerts This action has been closed-out on 14/07/2016.
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
During regular product monitoring, wear on system cabling was identified. in particular, wear may occur at the cable outlet of the inner c-arm. this problem is not systematic, but occurs sporadically on individual systems throughout the lifetime of the system. suboptimal routing of the cable may result in increasing wear. without intervention to manage this wear, damage to cabling may result in limited functionality and, in the worst case, system failure where a procedure may need to be terminated.
Acción
The existing cable routing at the C-arm will be modified to prevent cable damage. The following
hardware modification will be implemented in the field :
1. A modified cable outlet to provide additional space for the cabling.
2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area
most at risk of wear
All systems will be checked to determine if there is existing damage to cabling. Where damage
is observed, the entire cable harness will be replaced. This action has been closed-out on 14/07/2016.
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
Intuitive surgical has received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in labelling for the da vinci s, si or si-e surgical system, instruments and accessories.Intuitive surgical is initiating a correction related to labelling updates to distributed user manuals, instructions for use (ifu), quick reference guides (qrg)and the natural rubber latex qrg as well as an instrument release kit (irk) for use with da vinci surgical systems, instruments and accessories. the labelling updates have been implemented to incorporate user feedback not previously addressed.
Acción
Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016.
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
It has been determined that the stop solution that was supposed to have been filled at a 30 ml volume had only been filled at a 25 ml volume. this could result in running out of stop solution when using automation.
Acción
Alere is sending their customers a second bottle of correctly labelled stop solution for each kit supplied. In the interim, end users are advised to ensure that there is sufficient stop solution to complete the run prior to sample set-up. 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
Siemens has identified a potential malfunction which can occur when composed images are flipped on the integrated imaging system flourospot compact. when composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. the affected images and associated annotations such as labels (e.G. r/l) may show incorrectly.The corrupt image information might lead to an incorrect diagnosis.
Acción
Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.
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 expiration date on the label is incorrect. the affected sterile product components (comprising of a locking clip and a drive shaft seal packaged as separate parts) were labelled with expiration dates of 10 years rather than 2 years from the date of manufacturer.
Acción
Synthes is advising their customers to check inventory and to quarantine and return any affected units. 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
Following the assessment of the risk/benefit profile during audit by the notified body, sgs, a review of the company’s historical clinical evidence for the endobarrier has been undertaken. resulting from this review gi dynamics is updating the endobarrier’s indications for use, contraindications and possible adverse events to ensure adequate risk mitigation. the change in indication specifically aims to reflect that the obesity indication includes a restriction to patients with a body mass index (bmi) = 30 kg/m2.
Acción
Emergo is notifying their customers of the additional warnings, contraindications and limitations to the indications. Surgeons are advised that any patients implanted with the device contrary to the additional safety information should be monitored closely for the potential complications and adverse events. The decision to remove the EndoBarrier Gastrointestinal Liner System should take into consideration the patients clinical history in the context of the new information in the IFU. This action has been closed-out on 03/05/2016.
For additional information see http://tga.gov.au/alert/endobarrier-gastrointestinal-liner-delivery-system .
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 manufacturer has received sporadic notifications of postoperative opacification of the lentis hydrosmart inta ocular lenses (iol’s) in glass vials of all implanted hydrosmart iol’s since 2006. analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the iol material and the fluctuating, batch related presence of silicone residues on some iol’s. such residues may potentially change the iol surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. these deposits may compromise the optical transparency of the iol, potentially leading to a reduction in the patient’s visual acuity.
Acción
Customers are requested to inspect their stock and quarantine any affected units in preparation for return to Device Technologies.
Surgeons are advised that if postoperative opacification is observed to evaluate visual acuity levels and consider surgical IOL replacement if visual acuity is compromised in face of the patient’s individual conditions and needs. Intraocular lens replacement is the only recommended treatment for postoperative calcification of the IOL leading to compromise of visual acuity. In some cases postoperative opacification of the IOL may present bio- microscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness and avoid YAG laser capsulotomy in patients with an opacificied IOL since this procedure may affect the IOL replacement if needed in the future.
Please see http://www.tga.gov.au/alert/lentis-hydrosmart-intraocular-lenses-supplied-glass-vials .
This action has been closed-out on 4/08/2016.
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
Certain batches of actim partus dipsticks (used in the management of suspected preterm delivery) have shown increased non-specific binding during late stages of the 24 month shelf-life of the product. this issue increases the risk of false-positives results. the issue does not affect negative results which are still valid.
Acción
Replacement stock will be available by the end of January 2015. In the interim, customers are advised to check inventory and amend the expiry date on the primary container to reflect the new expiry date provided in the customer letter. This action has been closed-out on 07/07/2016.