Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that this field action is in a global scope and that there was no receipt of any claim in Brazil. Further informs that this recall does not apply to cannulae with 8 digit lot numbers packed with the Amvisc Plus product; also does not apply to the viscoelastic contained in the glass syringes of the Amvisc Plus product. To date, no notifications have been identified in the NOTIVISA. UPDATE: The company updated the information on 1/30/2013 and added two more batches affected by the field action: D100016A and D090105D. For more information, please contact Customer Service at 08007026464, or e-mail: maria.iung@bausch.com
Causa
Bausch + lomb, inc. recently identified that some disposable canisters (with a 4-digit batch number) supplied with the dvo amvisc plus are not fitting properly to the luer-lock in the sterile glass syringes of amvisc plus. disposable cannulae with 4-digit lot numbers may leak viscoelastic material or dislodge the syringe during injection. the immediate consequence of cannula detachment during intraocular use could involve damage to the intraocular tissue, which may or may not have far-reaching consequences, depending on the specific tissue involved and the nature of the injury.
Acción
Discontinue use of the affected lots of Amvisc Plus DVO immediately.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
The National Health Surveillance Agency - Anvisa - hereby informs that, to date, there is no report of adverse reactions involving this product in its Database of Notifications of Adverse Events of Health Products. The company BL Indústria Ótica Ltda reported that in Brazil there is, as of today, no case of Fesarium infection involving the product ReNu with Moisture LOC - Multiação Solution. Anvisa will continue to follow the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.//////////Additional information access: http: // www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/822.htm
Causa
The us food and drug administration (fda) and the us centers for disease control and prevention (cdc) have published on the fda website at http://www.Fda.Gov/bbs/topics/news/2006/ new01354.Html, an alert to healthcare professionals and contact lens wearers about the growing number of eye infections caused by the fusarium fungus in the united states. although not so frequent in that country, this type of infection is serious, since it can cause permanent blindness. according to the article, some patients reported loss of vision, requiring corneal transplantation. the fda and the cdc are investigating 109 cases of suspected fusarium contamination in 17 us states. the cause has not yet been detected. of the 30 cases investigated, 28 were users of contact lenses and 2 were non-users. of the 28 users, 26 reported using the product contact lens solution brand renu moisture loc, manufactured by the american company bausch & lomb, or a generic company of the same company, within a month before presenting the infection. five other users reported having used other solutions concurrently, and nine patients reported sleeping with their lenses. the alert highlights cases of corneal infection with fusarium fungus in asia in contact lens wearers in november 2005. in february 2006, bausch & lomb voluntarily suspended the sale of renu multipurpose solutions in singapore and hong kong, after the various notifications of infection among contact lens wearers. in brazil the product renu is imported and distributed by the company bl indústria ótica ltda - baush & lomb.
Acción
- In the United States, the CDC is working on investigations with the company Bausch & Lomb to identify other possible causes, in order to act in the prevention and control of this type of infection. - The American Bausch & Lomb Company informed the FDA that it voluntarily halted the marketing of the product ReNu Moisture Loc during the investigation process and requested that all users of contact lenses that make use of the product in question be careful and report to their respective ophthalmologists any signs or symptoms of eye infection. - In Brazil, BL Indústria Ótica Ltda informed Anvisa that it will take the following preventive / corrective actions in relation to the investigation process, which is in progress: 1) Adoption of control measures in the Brazilian territory, implying the suspension of the commercialization of the product in Brazil until the conclusion of the investigations; 2) Send samples of lots that are in the company's stock, for analysis in an external laboratory; 2) Availability, until Monday, April 17, of information on the company's website including a release with the main information. This release is being passed on to all the commercial area of the company BL Indústria Ótica Ltda., For visits to the main clients, aiming to clarify doubts; 3) Definition, until April 17, 2006, of new strategies of action, for the products that are in the stock of the company; 4) Preparation of a document explaining the situation and training of all its SAC team, in order to support the questions and doubts coming from consumers. The company informs that all the contacts are being registered by the SAC and that to the moment no complaint is related to the appearance of fungi. 5) Communication to Anvisa of new facts that affect the current strategy for the treatment of this situation.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
To date, there are no records of product-related notifications in the National Notification System for Health Surveillance - NOTIVISA. Anvisa is following this action.
Causa
The manufacturer of the product has identified the presence of silicone residue in batches of the products mentioned, which can cause from oversight or discomfort to severe eye pain or injury requiring medical treatment. symptoms, however, may vary from individual to individual.
Acción
For professional ophthalmologists and distributors, the company determines that affected lots are identified and segregated. To the patients, the search of their doctor for judicious evaluation.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: alcon cypass micro-stent
medical device manufacturer, alcon, has issued a medical device safety alert concerning its cypass micro-stent. the locally affected devices are identified as follow:
model number: 241 (8065754001)
lot number: fg122017005, fg112017003 & fg112017005
the manufacturer is conducting a voluntary field safety corrective action (withdrawal) of all versions of the cypass micro-stent. the stent is indicated for use in the reduction of intraocular pressure in adult patients with mild to moderate primary open-angle glaucoma (poag).
the two-year compass study, which served as a basis for regulatory approvals of the cypass micro-stent for use in conjunction with cataract surgery, included an evaluation of endothelial cell loss (ecl). at two years post-surgery there was little difference in ecl between the cypass micro-stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related ecl.
the compass-xt study was designed to collect safety data on the subjects who participated in the compass study for an additional three years, with analysis of the completed data set at five years post-surgery. at five years, the cypass micro-stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. a healthy corneal endothelium is responsible for corneal clarity, which is necessary for good vision. endothelial cells do not replicate, and when they are traumatized they are permanently lost. when the number of cells remaining goes below a critical threshold corneal edema (swelling) ensues. corneal decompensation frequently follows, leading to loss of corneal clarity and a subsequent decline in vision. treatment to regain corneal clarity often requires a corneal transplant.
based on information currently available, surgeons should consider the following recommendations for evaluating and managing patients who have been implanted with the cypass micro-stent:
the manufacturer recommends that all patients who have been implanted with a cypass micro-stent undergo post-operative gonioscopy (if not performed previously) to assess stent position, and periodic assessments of endothelial cell density using specular microscopy;
surgeons who are considering stent adjustment or removal should review the information in the cypass micro-stent instructions for use (ifu). healing response and progressive engagement of implant retention features must be factored into the decision to remove the cypass micro-stent after the immediate postoperative period (i.E., after 1 month postoperative). surgeons should consider less invasive intervention such as positional adjustment or trimming of the cypass micro-stent proximal end as a first alternative to device removal. it is highly recommended that surgeons consult the manufacturer prior to device removal;
after the immediate postoperative period, trimming of the proximal end of the cypass micro-stent may be considered when the anterior position of the stent appears likely to compromise corneal endothelial health. there is limited clinical data on the effects trimming may have on ecl. surgeons should consider the risks of further endothelial cell trauma caused by the trimming procedure against the potential benefits of the procedure. a procedure for stent trimming is set out in the ifu.
in addition, the manufacturer advises surgeons to immediately cease implanting the cypass micro-stent. affected users should quarantine any unused products and product removal is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 29 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of amo contact lens solution consumers of amo complete moistureplus contact lens solution are urged to stop using the product immediately following a voluntary recall of the product by its manufacturer, advanced medical optics (amo).
the recall was initiated by amo following reports of acanthamoeba keratitis cases, a rare but serious infection of the cornea, in the united states . "dh is closely monitoring the recall," a spokesman of the department of health (dh) today (may 26) said.
information provided by the local importer of the product, amo asia limited, showed that recall action is in progress to take off the product from the shelf at the retailer level and to operate a hotline for enquiries.
the spokesman said, "contact lens wearers should discontinue using the product immediately and consult their doctor if they have eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye and excessive tearing or other eye symptoms."
he said that dh would liaise with the hospital authority and private eye doctors for more information and to step up surveillance on the associated eye infection.
the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
ends
saturday, may 26, 2007.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of avaira and biocomfort xo contact lenses the department of health (dh) today (november 16) endorsed the recall of avaira and biocomfort xo contact lenses in hong kong as the product’s manufacturer in the united states, coopervision, has expanded its global recall of the avaira brand product line of contact lenses announced in august this year.
a dh spokesman said the product’s local distributor, coopervision hong kong revealed that the lenses are being recalled because of the presence of silicone oil residue which may cause hazy vision or discomfort, severe eye pain or even eye injuries requiring medical treatment.
the spokesman said that coopervision had recalled its avaira toric and biocomfort xo toric contact lenses in august this year, following complaints of discomfort and/or blurred vision from consumers.
he further explained that in view of possible consumer safety concern and to avoid market confusion, a total recall of avaira and biocomfort xo contact lenses in hong kong is a prudent measure.
dh will alert the hospital authority, private hospitals, relevant healthcare institutions, medical and optometrists associations about the matter. the company has also set up a hotline at 3718 0688 to answer enquiries.
"members of the public should cease using the product if they feel unwell, and consult their healthcare providers. dh will continue the investigation and closely monitor the recall."
ends/ wednesday, november 16, 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of avaira toric and biocomfort xo toric contact lenses subsequent to department of health’s (dh’s) advice on suspension of use of avaira toric contact lenses over the weekend, the dh today (august 22) endorsed the recall of the avaira toric contact lenses and another product biocomfort xo toric contact lenses because further information from the distributor, coopervision hong kong, revealed that the product marketed as biocomfort xo toric brand, was the same product as avaira toric contact lenses in hong kong.
a dh spokesman said upon further investigation, coopervision revealed that both the biocomfort xo toric and avaira toric were manufactured by the same manufacturer and the same production line. the biocomfort xo toric had been directly marketed only to the members of the hong kong association of private practice optometrists (appo) at their shops.
dh advised over the weekend that consumers should suspend use of avaira toric contact lenses. the advice followed the recall of avaira toric in the united states, australia, canada, germany, italy and spain after investigating into complaints of discomfort and/or blurred vision from consumers, which were likely to be due to transient swelling of the surface layer of the corneas brought about by a small amount of residues on the lens. consumers should also suspend the use of biocomfort xo toric because of the same defect.
the spokesman further explained that in view of possible consumer safety concern, a total recall of the two products is a prudent measure. coopervision admitted that as revealed by the information at hand, the two products were the affected products identified so far. dh will continue the investigation.
dh had already alerted the hospital authority, private hospitals, relevant healthcare institutions and medical associations about the matter. coopervision hongkong has issued a letter to related eye care practitioners regarding the recall. the company has also set up a hotline at 3718 0602 to answer enquiries between 9 am and 5 pm from monday to friday.
the spokesman said dh has so far not received any adverse reports arising from use of the products.
"members of the public should consult their healthcare providers when in doubt and in particular, if they feel unwell after using the products. dh will continue the investigation and closely monitor the recall.”
ends/.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Suspend use of avaira toric daily contact lenses advisable the department of health (dh) today (august 20) advises consumers to suspend use of avaira toric daily wear contact lens, pending dh's investigation. this is because the medical device's us manufacturer, coopervision is already embarking on recall of specific lots of the lens voluntarily, both in the states and also abroad in australia, canada, germany, italy and spain, amongst others, following complaints of discomfort and/or blurred vision from consumers.
the appeal is made after dh has assessed into the situation with the information provided by the manufacturer's greater china regulatory affairs office, which also revealed that the affected products have been distributed in hong kong.
"dh is being told that, working with the fda, the us manufacturer reckons the complaints were likely due to transient swelling of the surface layer of the cornea. in turn, this oedema could have been brought about by a small amount of residues on the lens," a dh spokesman quotes.
"although the number of complaint reports is small, the regulatory affairs office reports that the us manufacturer deems its recalls both in the us and overseas to be in the best interests of its customers," the spokesman adds.
the spokesman confirms that thus far, dh has not received any adverse reports arising from the use of the device.
"however, given that the notifying regulatory affairs office cannot provide dh with adequate information on the incriminated lots and in view of possible consumer safety concern, we consider it prudent to advise members of the public to stop using the product for the moment, pending our investigation finding," the spokesman explains the rationale for dh's management.
the spokesman urges all healthcare providers and local traders who have the affected product in hand to suspend supply temporarily. in addition, they should also report suspected adverse incidents to dh.
"members of the public should consult their healthcare providers when in doubt and in particular, if they feel unwell after having used the product. the manufacturer also provides a hotline 3718 0602, 9am to 5pm, monday to friday for answering public enquiry," the spokesman remarks.
ends/ sat, 20 aug 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bausch & lomb disposable cannulas provided with amvisc and amvisc plus sodium hyaluronate
medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning disposable cannulas with 4-digit lots numbers provided with amvisc and amvisc plus.
bausch & lomb, inc. recently identified that some disposable cannulas (with 4-digit lot numbers) provided with the amvisc or amvisc plus ophthalmic viscosurgical device (ovd) are not properly engaging to the luer-lock on the amvisc and amvisc plus sterile glass syringes. the disposable cannulas with 4-digit lot numbers may leak viscoelastic material or detach from the syringe during injection. in rare incidences, detachment has resulted in serious patient injury.
this recall is limited to cannulas with 4-digit lot numbers pre-packaged with some amvisc and amvisc plus sodium hyaluronate in sterile glass syringes. it does not include cannulas with 8-digit lot numbers pre-packaged with some amvisc and amvisc plus ovd, nor does it include the amvisc or amvisc plus ovd in the glass syringes themselves.
the manufacturer advised the users to discontinue the use of the affected products immediately. the affected products should continue to be refrigerated, but placed in quarantine.
according to the local supplier, the affected devices were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 16 november 2012.
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
Forum is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. it is intended to work with other forum applications.Forum correctly displays the optical coherence tomogram (oct) retinal b-scan when initially rendered, but a different b-scan tomogram is potentially displayed on subsequent renderings within a user session.Therefore, in certain circumstances an incorrect oct retinal b-scan tomogram scan may be displayed when retrospectively reviewing the available scans.This gives rise to a risk of a healthcare professional making a medical decision for the patient after viewing the wrong scan to what they requested.No incidents have been reported in australia or new zealand.
Acción
An initial workaround is provided to users in the Customer Letter whilst a permanent Software fix is being developed for rollout in February 2015. 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
Inova has identified an issue with two lots of the ez-load lens delivery system ez-28v, an intraocular lens inserter used to insert sofport intraocular lenses (iols). some inserters have been found to have a hook-like flash located near the tip area. this flash catches the leading haptic causing a kink. whilst mildly bent haptics can be restored to acceptable configuration intra-operatively using surgical instruments, a severely kinked haptic which cannot be restored can result in injury to the intraocular structures.
Acción
iNova is advising users to inspect their stock of EZ-Load Lens Delivery System (EZ-28V) immediately and quarantine any affected lots. iNova will arrange for stock collection and will issue credit for returned stock.
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 operating instructions for sterilisation (version 2) were either missing or obsolete. the new operating instructions (version 3) contain specific time and temperature for sterilisation. failure to follow the new operating instructions may result in potential adverse events, including eye infections.
Acción
iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017.
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
Alcon has identified an insufficient seal on the outside packaging that could potentially affect the sterility of the product. the use of non-sterile vitrectomy probes in surgery has the potential to result in patient infection or inflammation and may lead to serious injury and sequelae, including loss of vision.. at this time, no adverse events or complaints have been confirmed related to the accurus vitrectomy probe lots impacted by this issue. regular post-operative patient follow-up may enable the surgeon to detect early potential abnormal inflammatory reaction and/or infection, which may reduce the severity of the ensuing event.
Acción
Customers are advised to immediately stop further use of the affected lots and to segregate them to ensure that they are not used. Alcon will provide reimbursement for all returned product This action has been closed-out on 9/08/2016.
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
Inspections findings by the fda noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. no injuries have been reported for viscocel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
Acción
Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.
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
Inova pharmaceuticals (australia) pty ltd (inova) is conducting an urgent recall of 82 lots of 11 laseredge knife skus used in ophthalmic surgery due to an atypical number of dull blade complaints. if excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.Patients undergoing posterior segment surgery (e.G. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. the likelihood of adverse events associated with dull blades is very low.
Acción
Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
Coopervision, after the investigation of the avaira manufacturing lines, has detected that certain batches of avaira sphere contact lenses do not meet the quality requirements due to the presence of a residue (silicone oil). the presence of this residue can cause blurred vision, discomfort, severe eye pain or eye injuries that require medical treatment. not all patients experience the same symptoms.