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
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
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.
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
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
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.
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.
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.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Notas adicionales en la data
3rd Party Publications
Causa
Background information or related documents:
the irish medicines board is aware that bausch and lomb have:
voluntarily stopping shipment of all renu moisture loc solution manufactured at its facility in greenville, united states
advised retailers in the us to remove the renu moisture loc solution from their shelves temporarily
recommended that customers in the us switch to another lens care solution
this action was taken following multiple reports of fusarium keratitis among contact lens users in singapore, hong kong and the us. the bausch and lomb investigation into this issue is still ongoing and has not, to date, identified the cause of the problem. bausch and lomb have informed the imb that no renu moisture loc solution manufactured at the greenville plant is supplied to the european market.
bausch and lomb have indicated to the imb that the product supplied to the european market is manufactured at the bausch and lomb facility in italy. to date there have been no confirmed reported incidents of fusarium keratitis related to product manufactured at this european plant. this product is also manufactured in two other plants, in india and china. bausch & lomb have indicated that no confirmed incidents have been identified relating to renu moisture loc manufactured in these plants either.
as such, at this time bausch and lomb do not intend to stop the supply of product in europe.
the imb will continue to monitor the issue and will maintain close communication with bausch and lomb and other regulatory agencies.
recommendations:
the imb recommends that any irish customers who have purchased this product outside the european union or from an internet site should check the product label to determine where it was manufactured. irish customers should discontinue use of any product manufactured in the us and contact bausch and lomb if they have any concerns.
the imb recommends that contact lens users observe good contact lens hygiene practice and follow any recommendations provided by the manufacturer, their optician or other healthcare professional especially in relation to storage, cleaning and insertion of their contact lenses. contact lens users who experience eye symptoms such as pain, redness, excessive tear formation, abnormal sensitivity to light, blurred vision, discharge or swelling remove the contact lenses, discontinue use and consult a doctor.
the imb also recommend that healthcare professionals / clinicians with patients presenting with possible eye infections should consider fungal infections as a potential causative organism, investigate accordingly, preserve contact lenses and solutions for analysis, refer the patient if appropriate, and report contact lens related infections to the manufacturer.
bausch and lomb have set up a free phone number for irish customers 1800 409077. further recommendations and further information can be found on the bausch & lomb website
www.Bausch.Com
and on the website of the food and drug administration
www.Fda.Gov/bbs/topics/news/2006/new01354.Html
in the united states.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Viscoelastic Surgical Aid - Product Code LZP
Causa
Finger flange on the bd 1% ovd syringe can disengage during cataract surgery and and may lead to injury.
Acción
Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows:
Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement.
Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accessories solution ultrasonic cleaners for lenses / products contact lens care rigid gas permeable - Product Code MRC
Causa
The product failed to meet out of specification shelf life at the 9 months time point. this could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
Acción
Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Endotoxin levels above specifications have been noted in some syringes tested for lot number ud30654 of the amo healon d ophthalmic viscosurgical device. endotoxin levels above the maximum usp level may be potential causes of an inflammatory response and/or tass in patients following surgery.
Acción
On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form.
The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit.
The customers were asked to undertake the following actions:
(1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654.
(2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days.
The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Ophthalmic Cannula - Product Code HMX
Causa
Product labeled as 4 mm high viscosity injector tip contains a 6 mm tip.
Acción
BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
contact lens solution - Product Code LPN
Causa
Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility.
because of this production-line issue at the firm''s plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
Acción
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
contact lens solution - Product Code LPN
Causa
Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility.
because of this production-line issue at the firm''s plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
Acción
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
contact lens solution - Product Code LPN
Causa
Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility.
because of this production-line issue at the firm''s plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
Acción
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
contact lens solution - Product Code LPN
Causa
Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility.
because of this production-line issue at the firm's plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
Acción
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intraocular Lens - Product Code HQL
Causa
These specific serial numbers of lenses are being recalled because amo has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
Acción
On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express).
Included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility.
AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. AMO will provide updates to the FDA, including all information regarding the recall effectiveness and test results obtained as part of our continuing investigation, as part of the recall progress reports.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
contact lens solution - Product Code LPN
Causa
Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility.
because of this production-line issue at the firm's plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
Acción
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Contact lenses - Product Code LPL
Causa
Out of specification lens curve.
Acción
Consignees were notified via traceable mail on 09/13/2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Contact lenses - Product Code LPL
Causa
Out of specification lens curve.
Acción
Consignees were notified via traceable mail on 09/13/2006.