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  • Dispositivo 544
  • Fabricante 31827
  • Evento 694
  • Implante 87
Retiro De Equipo (Recall) de Alcon MONARCH III C Cartridge
  • Tipo de evento
    Recall
  • ID del evento
    75049
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0978-2017
  • Fecha de inicio del evento
    2016-09-05
  • Fecha de publicación del evento
    2017-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149191
  • Notas / Alertas
    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
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • Causa
    The intraocular lens could become lodged within the cartridge.
  • Acción
    Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-3058.
Retiro De Equipo (Recall) de Phacofragmentation System
  • Tipo de evento
    Recall
  • ID del evento
    73767
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1597-2016
  • Fecha de inicio del evento
    2014-10-06
  • Fecha de publicación del evento
    2016-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144937
  • Notas / Alertas
    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
    Unit, phacofragmentation - Product Code HQC
  • Causa
    The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the infiniti ultrasound packs.
  • Acción
    The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
Retiro De Equipo (Recall) de IOL Master 500
  • Tipo de evento
    Recall
  • ID del evento
    72564
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0358-2016
  • Fecha de inicio del evento
    2015-10-27
  • Fecha de publicación del evento
    2015-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141531
  • Notas / Alertas
    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
    Biomicroscope, slit-lamp, ac-powered - Product Code HJO
  • Causa
    Iol master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong iol power data.
  • Acción
    Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
Retiro De Equipo (Recall) de IOL Master 5.5
  • Tipo de evento
    Recall
  • ID del evento
    72564
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0357-2016
  • Fecha de inicio del evento
    2015-10-27
  • Fecha de publicación del evento
    2015-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141530
  • Notas / Alertas
    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
    Biomicroscope, slit-lamp, ac-powered - Product Code HJO
  • Causa
    Iol master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong iol power data.
  • Acción
    Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
Retiro De Equipo (Recall) de Biotrue ONEday (nesofilcon A) lenses
  • Tipo de evento
    Recall
  • ID del evento
    72161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0206-2016
  • Fecha de inicio del evento
    2015-09-03
  • Fecha de publicación del evento
    2015-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140144
  • Notas / Alertas
    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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. complaints of halo or poor visual acuity.
  • Acción
    On 9/3/2015, the distributors received the Medical Device Recall Letter (dated 9/2/2015) via e-mail. Medical Device Recall Letters (dated 9/2/2015) and Customer Acknowledgement Cards were hand delivered to the direct customers via Bausch + Lomb Sales Representatives starting on 9/14/2015 or sent via FedEx if consignee is not a B+L account. The letter informs the accounts of the recall and instructs them to direct any consumers who would like to report a product complaint, arrange for a product exchange, or obtain more information on the product recall to contact the Bausch + Lombs Consumer Affairs Team at 1-800-553-5340 or via e-mail at BLCustomerCare@bausch.com. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.
Retiro De Equipo (Recall) de Device Recall AMO brand WaveScan WaveFront System
  • Tipo de evento
    Recall
  • ID del evento
    56394
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1374-2011
  • Fecha de inicio del evento
    2010-07-13
  • Fecha de publicación del evento
    2011-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93449
  • Notas / Alertas
    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
    Excimer laser system - Product Code LZS
  • Causa
    The failure to comply with minimum system requirements, increased system errors could result, and a miscreated treatment table (incorrect lasik refractive treatment) could result.
  • Acción
    Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to take the following actions: Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530. For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com. For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.
Retiro De Equipo (Recall) de Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Con...
  • Tipo de evento
    Recall
  • ID del evento
    56329
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2292-2010
  • Fecha de inicio del evento
    2010-06-07
  • Fecha de publicación del evento
    2010-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93240
  • Notas / Alertas
    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
    Implant, Eye Sphere - Product Code HPZ
  • Causa
    Integrated orbital implants, inc. has initiated a recall of it's sterile bio-eye hydroxyapatite orbital implant and conformer due to a labeling issue in which the expiration date of the product was omitted.
  • Acción
    Customers were contacted by telephone and email
Retiro De Equipo (Recall) de Device Recall Peregrine 20 GA Endo Ocular Adjustable Laser Probe (S...
  • Tipo de evento
    Recall
  • ID del evento
    56271
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2399-2010
  • Fecha de inicio del evento
    2010-07-19
  • Fecha de publicación del evento
    2010-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93106
  • Notas / Alertas
    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 Laser - Product Code HQF
  • Causa
    Product did not have proper 510(k) clearance.
  • Acción
    A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.
Retiro De Equipo (Recall) de Device Recall BIOM PACK
  • Tipo de evento
    Recall
  • ID del evento
    56246
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2221-2010
  • Fecha de inicio del evento
    2010-05-12
  • Fecha de publicación del evento
    2010-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93054
  • Notas / Alertas
    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
    Ocular Surgery Irrigation Device - Product Code KYG
  • Causa
    Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
  • Acción
    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
Retiro De Equipo (Recall) de Device Recall CORNEA COAT
  • Tipo de evento
    Recall
  • ID del evento
    56246
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2220-2010
  • Fecha de inicio del evento
    2010-05-12
  • Fecha de publicación del evento
    2010-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93053
  • Notas / Alertas
    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
    Ocular Surgery Irrigation Device - Product Code KYG
  • Causa
    Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
  • Acción
    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
Retiro De Equipo (Recall) de Device Recall Polycarbonate prescription single vision lenses for u...
  • Tipo de evento
    Recall
  • ID del evento
    56120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1568-2011
  • Fecha de inicio del evento
    2010-06-30
  • Fecha de publicación del evento
    2011-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92699
  • Notas / Alertas
    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
    Lens, spectacle, non-custom (prescription) - Product Code HQG
  • Causa
    The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. lnad made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.
  • Acción
    Luxottica Optical Manufacturing sent notification letters on June 30, 2010, to their customers informing them of the problem. Customers were instructed to complete the enclosed Sport Goggle Return Form, and to indicate whether they would like a replacement pair of goggles or a refund. Place the completed Sport Goggle Return Form and their sport goggles (without the sport goggle case) in the envelope provided and return it to the firm via the United States Postal Service. Customers were instructed not to return to the retail store where purchased. If customers were unable to return their sport goggles because they were lost or discarded, customers should complete the appropriate information on the Sport Goggle Return Form, being sure to indicate whether they would like a replacement pair of goggles or a refund, and then sign the form. Place the completed Sport Goggle Return Form in the envelope provided and return it to the firm via the United States Postal Service. For any questions, call 1-877-488-2407. They instructed their customers to return the product for replacement or refund.
Retiro De Equipo (Recall) de Device Recall Lenstar LS 900
  • Tipo de evento
    Recall
  • ID del evento
    55857
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1897-2010
  • Fecha de inicio del evento
    2010-05-19
  • Fecha de publicación del evento
    2010-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92075
  • Notas / Alertas
    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
    Device, measuring, lens radius, ophthalmic - Product Code HLF
  • Causa
    During the creation of the lenstar ls 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for us distribution. the current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in.
  • Acción
    HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated. For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255.
Retiro De Equipo (Recall) de Device Recall Fancy i Color cosmetic lens
  • Tipo de evento
    Recall
  • ID del evento
    55807
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1756-2010
  • Fecha de inicio del evento
    2010-05-17
  • Fecha de publicación del evento
    2010-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91884
  • Notas / Alertas
    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
    Lenses, soft contact, extended wear - Product Code LPM
  • Causa
    Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
  • Acción
    Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed. For further information, contact Kim's Trading Inc. at 1-484-895-3773.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1227-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89255
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1226-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89254
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1225-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88914
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1224-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88911
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1223-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88910
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Tipo de evento
    Recall
  • ID del evento
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1222-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88909
  • Notas / Alertas
    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 - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Retiro De Equipo (Recall) de Device Recall Image Consultant (IC) Software
  • Tipo de evento
    Recall
  • ID del evento
    54633
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1176-2010
  • Fecha de inicio del evento
    2010-02-05
  • Fecha de publicación del evento
    2010-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88852
  • Notas / Alertas
    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
    Device, storage, images, ophthalmic - Product Code NFF
  • Causa
    Software not validated; inaccurate results may occur.
  • Acción
    On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.
Retiro De Equipo (Recall) de Device Recall Bausch & Lomb Stellaris Vision Enhancement System
  • Tipo de evento
    Recall
  • ID del evento
    54268
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1664-2010
  • Fecha de inicio del evento
    2010-01-15
  • Fecha de publicación del evento
    2010-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88016
  • Notas / Alertas
    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
    instrument, vitreous aspiration and cutting, ac-powered cord - Product Code NFJ
  • Causa
    The ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
  • Acción
    A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.
Retiro De Equipo (Recall) de Device Recall Bausch & Lomb Millennium Microsurgical System
  • Tipo de evento
    Recall
  • ID del evento
    54268
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1663-2010
  • Fecha de inicio del evento
    2010-01-15
  • Fecha de publicación del evento
    2010-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88015
  • Notas / Alertas
    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
    instrument, vitreous aspiration and cutting, ac-powered cord - Product Code NFJ
  • Causa
    The ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
  • Acción
    A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.
Retiro De Equipo (Recall) de Device Recall Bausch & Lomb MicroFlow 2.2 30 Phaco Needle
  • Tipo de evento
    Recall
  • ID del evento
    54200
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1730-2010
  • Fecha de inicio del evento
    2010-01-08
  • Fecha de publicación del evento
    2010-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87888
  • Notas / Alertas
    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
    unit, phacofragmentation - Product Code HQC
  • Causa
    Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
  • Acción
    The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
Retiro De Equipo (Recall) de Device Recall Bausch & Lomb Thin Tip 30 angled Phaco Needle
  • Tipo de evento
    Recall
  • ID del evento
    54200
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1729-2010
  • Fecha de inicio del evento
    2010-01-08
  • Fecha de publicación del evento
    2010-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87887
  • Notas / Alertas
    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
    unit, phacofragmentation - Product Code HQC
  • Causa
    Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
  • Acción
    The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
Retiro De Equipo (Recall) de Device Recall Bausch & Lomb Thin Tip 30 Phaco Needle
  • Tipo de evento
    Recall
  • ID del evento
    54200
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1728-2010
  • Fecha de inicio del evento
    2010-01-08
  • Fecha de publicación del evento
    2010-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87886
  • Notas / Alertas
    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
    unit, phacofragmentation - Product Code HQC
  • Causa
    Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
  • Acción
    The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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