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Vista de la lista Vista de las tarjetas
  • Dispositivo 544
  • Fabricante 31827
  • Evento 694
  • Implante 87
Staarvisc
  • Modelo / Serial
    Lot Number: B020122E
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    CA, MO, NC,VA
  • Descripción del producto
    Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. || P/N490-001 || Distributed by: STAAR Surgical Inc., Monrovia CA
  • Manufacturer
    Anika Therapeutics
  • 1 Event
    • Retiro De Equipo (Recall) de Staarvisc
Staarvisic II || Sodium Hyaluronate, 0.8 mL
  • Modelo / Serial
    Lot B041118C Exp Date 12/31/2005
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada and Puerto Rico
  • Descripción del producto
    Staarvisic II || Sodium Hyaluronate, 0.8 mL
  • Manufacturer
    Staar Surgical Co Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Staarvisic II || Sodium Hyaluronate, 0.8 mL
STAR ActiveTrak Excimer Laser System
  • Modelo / Serial
    All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
  • Descripción del producto
    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
  • Manufacturer
    Abbott Medical Optics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de STAR ActiveTrak Excimer Laser System
STAR Excimer Laser
  • Modelo / Serial
    All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
  • Descripción del producto
    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, || Milpitas, CA || The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
  • Manufacturer
    Abbott Medical Optics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de STAR Excimer Laser
STAR Excimer Laser System with Variable Spot Scanning
  • Modelo / Serial
    All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
  • Descripción del producto
    STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
  • Manufacturer
    Abbott Medical Optics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de STAR Excimer Laser System with Variable Spot Scanning
STAR IR Excimer Laser
  • Modelo / Serial
    All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
  • Descripción del producto
    STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC || Milpitas, CA || The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
  • Manufacturer
    Abbott Medical Optics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de STAR IR Excimer Laser
Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. |...
  • Modelo / Serial
    All Codes
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. || Sold under the following brand names: || Family Dollar || HomeBest || HEB || Meijer || Food Lion || health PRIDE || Stop and Shop || Super G || sunmark || Brite-Life || Wegmans || Our Family || Healthy Generations || GoodSense || Winn Dixie || Finast || Western Family || K C Pharmaceuticals
  • Manufacturer
    K C Pharmaceuticals Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. || Sold under the following brand names: || Family Dollar || HomeBest || HEB || Meijer || Food Lion || health PRIDE || Stop and Shop || Super G || sunmark || Brite-Life || Wegmans || Our Family || Healthy Generations || GoodSense || Winn Dixie || Finast || Western Family || K C Pharmaceuticals
Storz
  • Modelo / Serial
    Lot Number: B020122H
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    CA, MO, NC,VA
  • Descripción del producto
    Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use. || Product Number: 014-180A
  • Manufacturer
    Anika Therapeutics
  • 1 Event
    • Retiro De Equipo (Recall) de Storz
Venoscope Neonatal Transilluminator
  • Modelo / Serial
    The product is not lot coded on the exterior of the device and could not be identified by the consignee without disassembling the device to find the lack of an identifying mark.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Venoscope Neonatal Transilluminator, Model NT01
  • Manufacturer
    Venoscope LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Venoscope Neonatal Transilluminator
VersaVit
  • Modelo / Serial
    Lot number M546500 (1 each or box of 6 each), exp 10/2018
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
  • Descripción del producto
    25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
  • Manufacturer
    Synergetics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VersaVit
VersaVit
  • Modelo / Serial
    Lot number M543990 (1 each or box of 6 each), exp 10/2018 Lot number M545780 (1 each or box of 6 each), exp 10/2018 Lot number M569020 (1 each or box of 6 each), exp 01/2019 Lot number M578140 (1 each or box of 6 each), exp 02/2019
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
  • Descripción del producto
    25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
  • Manufacturer
    Synergetics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VersaVit
VersaVit
  • Modelo / Serial
    Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
  • Descripción del producto
    25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
  • Manufacturer
    Synergetics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VersaVit
VersaVit
  • Modelo / Serial
    Lot number M545040 (1 each or box of 6 each), exp 10/2018 Lot number M586070 (1 each or box of 6 each), exp 03/2019
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
  • Descripción del producto
    25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
  • Manufacturer
    Synergetics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VersaVit
Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
  • Modelo / Serial
    CX: Level 1 -M206191, Level 2-M206192, Level 3-M206193, Level 4-M206194. LX: Level 1-M301121, Level 2- M301122, Level 3- M301122, Level 4-M301124.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Descripción del producto
    Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
  • Manufacturer
    Beckman Coulter Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL
  • Modelo / Serial
    Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mLProduct Codes: AusVIS15, AusVIS20Batch Numbers: 13D02 (expiry 04/2015), 12A13 (expiry 01/2015), 12J08 (expiry 10/2014), 13B18 (expiry 02/2015), 12J02 (expiry 10/2014), 12G16 (expiry 07/2014), 12I04 (expiry 09/2014) and 12H20 (expiry 08/2014)Manufactured from September 01, 2011 to September 19, 2013ARTG Number: 132648
  • Clasificación del producto
    Ophthalmic Devices
  • Manufacturer
    Boucher & Muir Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL
Vitrectomy 25G Custom Surgical Pak
  • Modelo / Serial
    Lot #899513H (for Cat/Item #10240-03), 892675H (for Cat/Item #11077-03), 892670H (for Cat/Item #11187-02) and 894213H (for Cat/Item #13305-01).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
  • Manufacturer
    Alcon Laboratories, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitrectomy 25G Custom Surgical Pak
WaveLight FS 200 Femtosecond Laser System
  • Modelo / Serial
    Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.
  • Descripción del producto
    WaveLight FS200 Femtosecond Laser System || Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. || The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.
  • Manufacturer
    Wavelight AG
  • 1 Event
    • Retiro De Equipo (Recall) de WaveLight FS 200 Femtosecond Laser System
Zyoptix XP Microkeratome maxon motor
  • Modelo / Serial
    Serial numbers: 77318901, 77318902, 77318903, 77318904, 77318905, 77318907, 77318910, 77318911, 77318913, 77318914, 77318915, 77318917, 77318918, 77318919, 77318922, 77318923, 77318924, 77318929, 77318930, 77318931, 77318932, 77504010, 77504012, 77504017, 77732304, 77732306, 77732308, 77732309, 77732310, 77732311, 77732312, 77732313, 77732314, 77732315, 77898709, 77898711, 78080303, 78080307, 78080308, 78080309, 78080310, 78080312, 78080313, 78080314, 78080315, 78080320, 78080322, 78080331, 78080337, 78207103, 78207104, 78207106, 78207107, 78207108, 78207111, 78207113, 78207114, 78207115, 78207116, 78207117, 78207118, 78207119, 78207120, 78207121, 78207122, 78207123, 78207124, 78207125, 78207129.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
  • Descripción del producto
    Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
  • Manufacturer
    Bausch & Lomb Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Zyoptix XP Microkeratome maxon motor
Zyoptix XP Microkeratome tray
  • Modelo / Serial
    Tray/motor serial numbers: 11061/77318906, 10980/77318909, 11019/77318920, 11029/77318925, 11084/77318926, 10969/77504001, 11046/77504002, 11000/77504005, 11088/77504006, 11045/77504007, 11068/77504008, 11108/77504009, 10972/77504011, 11106/77504014, 11021/77504015, 11177/77732302, 11202/77732307, 11091/77732316, 11031/77732318, 11066/77898701, 11026/77898702, 11077/77898704, 11120/77898705, 11103/77898706, 11040/77898707, 11192/77898708, 11190/77898712, 11174/77898713, 11153/77898714, 11030/77898715, 11111/78080317, 11047/78080319, 11150/78080321, 10904/78080323, 11149/78080324, 11096/78080325, 11041/78080333, 11081/78080334, 11064/78080335, 11221/78080339, 11122/78080340, 11034/78080341, 11140/78080342, 11089/78207127
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
  • Descripción del producto
    Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
  • Manufacturer
    Bausch & Lomb Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Zyoptix XP Microkeratome tray
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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.