French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
AMO voluntarily recalls COMPLETE® MoisturePLUS maintenance solutions. This recall follows a report by the American Center for Disease Control and Prevention (CDC), where the risk of Acanthamoeba keratitis (current water amoeba) for users of this solution is estimated to be seven times higher (2 cases per year). million) for non-users. Although no contamination of the product has been established to date, and the risk of infection is very low, AMO, as a precautionary measure, recommends to patients to change maintenance solution while waiting for further information. This recall does not apply to other AMO products. The competent authorities have been informed by the company. This message is intended for pharmacists, ophthalmologists (01/06/2007) (110 ko) and opticians (01/06/2007) (113 ko).
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
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
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.
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
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
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.
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
"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."
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
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.
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.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Message regarding the withdrawal of contact lens care (June 28, 2007)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Bausch & Lomb safety note for disposable 27G cannulas delivered with viscoelastic Amvisc and Amvisc Plus
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Some 27g disposable cannulas manufactured by rhein medical, inc. provided with the amvisc or amvisc plus ovd are not properly engaging to the luer-lock on the amvisc and amvisc
plus sterile glass syringes. the 27g disposable cannulas may leak viscoelastic material or detach from the syringe during injection. immediate consequences of cannula detachment during intraocular use could include damage to intraocular tissue.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
A small opening (channel or tunnel) in the seal of the
outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Acción
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
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
Eyelid thermal pulsation system - Product Code ORZ
Causa
Complaints related to an error condition occurring during patient treatment where the fipiflow system automatically stopped treatment after detecting a problem with the activator.
Acción
The firm, TearScience, sent a "Medical Device Recall" letter dated September 9, 2016 to its consignees/customers on 9/13/2016. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email to: Customerservice@tearscience.com or mail to TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement.
For any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.