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  • Dispositivo 544
  • Fabricante 31827
  • Evento 694
  • Implante 87
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 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 CeeOn Heparin SurfaceModifie (HSM) PMMA
  • Tipo de evento
    Recall
  • ID del evento
    33849
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0097-06
  • Fecha de inicio del evento
    2005-10-05
  • Fecha de publicación del evento
    2005-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42556
  • 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
    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.
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 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 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 CSI Daily wear
  • Tipo de evento
    Recall
  • ID del evento
    36382
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0018-07
  • Fecha de inicio del evento
    2006-09-13
  • Fecha de publicación del evento
    2006-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48533
  • 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
    Contact lenses - Product Code LPL
  • Causa
    Out of specification lens curve.
  • Acción
    Consignees were notified via traceable mail on 09/13/2006.
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 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 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 Lipiflow Thermal Pulsation System
  • Tipo de evento
    Recall
  • ID del evento
    75163
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0093-2017
  • Fecha de inicio del evento
    2016-09-13
  • Fecha de publicación del evento
    2016-10-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149494
  • 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
    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.
Retiro De Equipo (Recall) de Bausch Lomb PeroxiClear Peroxide Solution
  • Tipo de evento
    Recall
  • ID del evento
    75324
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0651-2017
  • Fecha de inicio del evento
    2016-09-19
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150049
  • 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, soft lens products - Product Code LPN
  • Causa
    Product was found to contain excess residual levels of hydrogen peroxide.
  • Acción
    The firm, Bausch & Lomb, sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated 9/29/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter: review your inventory including floor displays; contact Stericycle, the firm conducting the product recall on behalf of Bausch & Lomb, to arrange for return of the product; and complete and return the Recall Acknowledgement Form to Stericycle Inc,, even if you do not have any of the product in your inventory, via Fax to 1-877-779-7814, email: BauschandLomb5833@Stericycle.com or phone: 1-877-877-0481. If you have any questions about this voluntary recall process or would like additional information, please contact Stericycle, Inc., the firm conducting the recall on behalf of Bausch & Lomb at 1-877-877-0481.
Retiro De Equipo (Recall) de AlgerbrushII
  • Tipo de evento
    Recall
  • ID del evento
    75915
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0983-2017
  • Fecha de inicio del evento
    2016-10-12
  • Fecha de publicación del evento
    2017-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151706
  • 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
    Burr, corneal, battery powered, rust ring removal - Product Code OHW
  • Causa
    According to firm ( bausch & lomb, inc. ) on june 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of sku 0816 c (pterygium burr medium diamond). further investigation found that repackaged algerbrush-ii and its accessories from april 30, 2012 to present, contained out of date operating instruction. therefore bausch & lomb is proposing a field correction to provide customer purchasing product from april 30, 2012 to june 20, 2016 with the current operating instruction.
  • Acción
    Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020
Retiro De Equipo (Recall) de CSI Flexible Wear
  • Tipo de evento
    Recall
  • ID del evento
    36382
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0019-07
  • Fecha de inicio del evento
    2006-09-13
  • Fecha de publicación del evento
    2006-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48534
  • 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
    Contact lenses - Product Code LPL
  • Causa
    Out of specification lens curve.
  • Acción
    Consignees were notified via traceable mail on 09/13/2006.
Retiro De Equipo (Recall) de CSI Toric
  • Tipo de evento
    Recall
  • ID del evento
    36382
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0020-07
  • Fecha de inicio del evento
    2006-09-13
  • Fecha de publicación del evento
    2006-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48535
  • 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
    Contact lenses - Product Code LPL
  • Causa
    Out of specification lens curve.
  • Acción
    Consignees were notified via traceable mail on 09/13/2006.
Retiro De Equipo (Recall) de Bausch & Lomb Boston Conditioning Solution, Original Formula
  • Tipo de evento
    Recall
  • ID del evento
    53873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0553-2010
  • Fecha de inicio del evento
    2009-10-30
  • Fecha de publicación del evento
    2009-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86782
  • 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 / 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.
Retiro De Equipo (Recall) de AERO IOL Injection System, Z28 Cartridges
  • Tipo de evento
    Recall
  • ID del evento
    78037
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0071-2018
  • Fecha de inicio del evento
    2017-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158541
  • 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 recommended storage temperature on the label is incorrect.
  • Acción
    Aaren Scientific sent an Urgent Medical Device Recall letter dated August 31, 2017. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1.Compare your inventory against the above list. 2. STOP using and REMOVE from your inventory all affected Z28 listed above. 3. Complete and return the attached Customer Reply Form EVEN IF YOU HAVE NO INVENTORY affected by this recall, to Aaren Scientific, Inc. Quality Management at (909) 937-1033 or email to Z28recall.med.us@ZEISS.com within 3 business days of receipt of this letter. Upon notification, Aaren Scientific, Inc. will supply you with a Return Good Authorization Number to replace all remaining customer inventory of the affected product immediately. Aaren Scientific, Inc. requires this information for reconciliation purposes with regulatory agencies. No other Aaren Scientific, Inc. Z28 Cartridges are affected by this action. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have inventory of any of the Z28 Cartridges with the batch numbers listed, please contact Customer Support at (909) 937-1033 to arrange pick up of lenses to be returned. Page 2 of 4 If you have product complaints or adverse events to report regarding the use of the Z28 cartridge, please inform Aaren Scientific, Inc. by calling. When reporting a complaint, please provide the Z28 cartridge batch number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. For questions regarding this recall call 909-906-5119.
Retiro De Equipo (Recall) de Biofinity XR Toric
  • Tipo de evento
    Recall
  • ID del evento
    79073
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0691-2018
  • Fecha de inicio del evento
    2017-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161281
  • 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
    The firm identified a labeling error affecting made-to-order (mto) biofinity xr toric blister labels. the primary blister reads biofinity multifocal toric in error, and should read biofinity xr toric. the outer carton correctly reads biofinity xr toric.
  • Acción
    Notifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273.
Retiro De Equipo (Recall) de COMPLETE MoisturePLUS & COMPLETE Amino Moist
  • Tipo de evento
    Recall
  • ID del evento
    36711
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0344-2007
  • Fecha de inicio del evento
    2006-09-15
  • Fecha de publicación del evento
    2007-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49201
  • 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
    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.
Retiro De Equipo (Recall) de ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
  • Tipo de evento
    Recall
  • ID del evento
    79152
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1209-2018
  • Fecha de inicio del evento
    2017-10-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162499
  • 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
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • Acción
    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Retiro De Equipo (Recall) de ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
  • Tipo de evento
    Recall
  • ID del evento
    79152
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1210-2018
  • Fecha de inicio del evento
    2017-10-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162501
  • 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
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • Acción
    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Retiro De Equipo (Recall) de Silicone Posterior Chamber Intraocular Lenses
  • Tipo de evento
    Recall
  • ID del evento
    36905
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0267-2007
  • Fecha de inicio del evento
    2006-10-31
  • Fecha de publicación del evento
    2006-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49546
  • 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
    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.
Retiro De Equipo (Recall) de 1DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
  • Tipo de evento
    Recall
  • ID del evento
    79152
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1211-2018
  • Fecha de inicio del evento
    2017-10-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162504
  • 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, contact, (disposable) - Product Code MVN
  • Causa
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • Acción
    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
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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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