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  • Dispositivo 544
  • Fabricante 31827
  • Evento 694
  • Implante 87
Device Recall Customed
  • Modelo / Serial
    LOTS: SL15180 (150619377) 30-JUN-16 SL15184 (150619377) 30-JUN-16 SL15229 (150619378) 31-AUG-16 SL15230 (150819814) 31-AUG-16 SL15231 (150820356) 31-AUG-16 SL15231 (150819816) 31-AUG-16 SL15231 (150819815) 31-AUG-16 SL15259 (150920355) 30-SEP-16 SL15261 (150920357) 30-SEP-16 SL15266 (150920358) 30-SEP-16
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900944 || CATARACT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case
  • Modelo / Serial
    Model #: VG4SNF, Lot: BE05200
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
  • Descripción del producto
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 || for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
  • Manufacturer
    Volk Optical Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case
Device Recall Epic 5100) Refractor and RT 3100 Refractor
  • Modelo / Serial
    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
  • Manufacturer
    Nidek Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Epic 5100) Refractor and RT 3100 Refractor
Device Recall VERION Image Guided System
  • Modelo / Serial
    Serial Numbers: 1017, 1119, 1123, 1125, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1139, 1142, 1147, 1150, 1153, 1155, 1161, 1165, 1168, 1172, 1178, 1181, 1182, 1183, 1188, 1190, 1191, 1193, 1196, 1197, 1198, 1199, 1201, 1203, 1206, 1207, 1220, 1226, 1228, 1230, 1232, 1250, 1256, 1258, 1259, 1421, 1433, 1435, 1439, 1451, 1452, 1506, 1508, 1509, 1523, 1536, 1548, 1559, 1562, 1565, 1568, 1581, 1597, 1606, 1628, 1632, 1649, 1661, 1663, 1668, 1671, 1694, 1696, 1705, 1716, 1726, 1729, 1798, 1816, 1818, 1820, 1824, 1829, 1921, 1922, 1934, 1937, 1938, 1940, 1942, 1954, 1957, 2057, 2069, 2086, 2092
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hungary, India, Indoesia, Isreal, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Panama, Philippines, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UK, Ukrain, United Arab Emirates
  • Descripción del producto
    VERION Reference Unit (Vision Planner) || Product Usage: || The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VERION Image Guided System
Device Recall Fixed eye Safety filters
  • Modelo / Serial
    Model Number : 3143270
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution
  • Descripción del producto
    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. || The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. || .
  • Manufacturer
    Laserex Systems Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Fixed eye Safety filters
Device Recall Optovue iVue and iVue 500
  • Modelo / Serial
    US and foreign (not yet provided) Software version 2016.0.0.127: Serial numbers:  21908, 26507, 26496, 26558, 22738, 26139, 26442, 25720, 25079, 25142, 23298, 21990, 23461, 24199, 25843, 26572, 26550, 22971, 26495, 22652, 26550, 22971, 26495, 22652, 25389, 23309, 23760, 21732-1, 23527, 20923, 21600, 21414, 20271, 23153, 22875, 23211. Software version 2016.1.0.127; Serial numbers forthcoming.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming
  • Descripción del producto
    iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) || Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and || measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.
  • Manufacturer
    Optovue, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Optovue iVue and iVue 500
Device Recall STAAR AQ CartridgeFP
  • Modelo / Serial
    1281706, 1282812
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US
  • Descripción del producto
    STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
  • Manufacturer
    Staar Surgical Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall STAAR AQ CartridgeFP
Device Recall phacofragmentation system
  • Modelo / Serial
    Serial Number 1601444801X
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to Illinois
  • Descripción del producto
    CENTURION Vision System
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall phacofragmentation system
Device Recall OPTICAL BIOMETER
  • Modelo / Serial
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
  • Descripción del producto
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. || Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
  • Manufacturer
    Nidek Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OPTICAL BIOMETER
Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar
  • Modelo / Serial
    Model PASCAL Synthesis (532/577). Serial numbers: United States: 79056215 79064615 77055414 79065715 79088615 79088415 79063115 79081015 79095816 79085715 77050213 77050313 77052113 77052913 79088916 79081615 77051913 77052313 77053113 79071415 79073815 77053613 79081515. ROW: 79087915 79073715 79074915 79075415 79075515 79076315   79076515   79076715 79076915   77055714   79050314 79050614   79050714 79050914 79051114 79051214 79051414 79051714 79052114 79052214 79052314 79052714 79052814 79052914 79053014 79053214 79053314 79054014 79054114 79054214 79054414 79054714 79054814 79055014 79055314 79055414 79055715 79057915 79058015 79058115 79058215 79059715 79059815 79064315 79065115 79065215 79065415 79065915 79067515 79067615 79067715 79068015 79068115 79068715 79069915 79070515 79071115 79072415 79072615 79072715 79072815 79072915 79073215 79073315 79073615 79077415 79077915 79078015 79079515 79082115 79084815 79086815 79086915 79087615 79088315 79089116 79090316 79090516 79090616 79093816 79094416 79095416 79095516 79074015 79074315 79074515 77052613 78051014 78051414 78051514 79051914 79053514 79053614 79053814 79053914 79054914 79056615 79057015 79057115 79057315 79057615 79058515 79060015 79060115 79060215 79060315 79060415 79060515 79060915 79061015 79061115 79061215 79061315 79061415 79061715 79062115 79062515 79062615 79062715 79062815    79063315    79063815    79063915 79064115 79064515 79064815 79065015 79065515 79066315 79066415 79066515 79066915 79068315 79068415 79068815 79070315 79070715 79070815 79070915 79071315 79071815 79072015   79080815 79080915   79081115 79082715 79082915 79083015 79084215 79085015 79087015 79087115 79093416 77055113 77055213 79068615 79069815 79091916 77055914 77053913 77054013 77054113 77054213 77054313 79077315 79091116 77055514 79058615 79059415 79071515 79063415 79066615 79063015 78050414 79061615 79062915 79066115 79070115 79092016 79092316 79092416 79079915.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.
  • Descripción del producto
    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed || conventionally.
  • Manufacturer
    Topcon Medical Laser Systems, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar
Device Recall LAUREATE World Phaco System
  • Modelo / Serial
    Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.
  • Descripción del producto
    LAUREATE World Phaco System
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LAUREATE World Phaco System
Device Recall Merge Eye Station
  • Modelo / Serial
    136 T1700 Capture Stations 46 T5810 Capture Stations
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.
  • Descripción del producto
    Merge Eye Station. || f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). || Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Eye Station
Device Recall Merge Eye Station
  • Modelo / Serial
    Merge Eye Station software versions: 11.6.0 and prior
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware, District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming. OUS: Czech Republic Algeria Belgium Brazil Canada Denmark France Germany Greece India Israel Italy Korea, Republic of Luxembourg Netherlands Poland Russian Federation Singapore United Kingdom
  • Descripción del producto
    Merge Eye Station || f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Eye Station
Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM
  • Modelo / Serial
    Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
  • Descripción del producto
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM
Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
  • Modelo / Serial
    All lots of lenses sold between 10/31/2013 to 10/31/2016
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
  • Descripción del producto
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
  • Manufacturer
    The See Clear Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
Device Recall LipiFlow
  • Modelo / Serial
    Model number LFD-1000 and LFD-1100, All lots
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide)
  • Descripción del producto
    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
  • Manufacturer
    Tearscience, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LipiFlow
Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12
  • Modelo / Serial
    Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009; NVE0002; OH00295; NC00185; CAE0016; COE0008; MI00131; GA00241; CAE0007; VAE0004; MI00131; CAE0031; AZ00167; COE0011; CA00561; PAE0003; TN00168; MNE0009; WA00246; CAE0047; OHE0005; WAE0008; MI00244; NY00473; CAE0007; WAE0008; NVE0002; WA00233; CAE0016.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
  • Descripción del producto
    Final Fit Software Version 1.11 and 1.12; || PC Based software installed outside Nidek EC-5000 Excimer Laser System. || Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
  • Manufacturer
    Nidek Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12
Device Recall EyeSuite i.8.2.1.0 Software
  • Modelo / Serial
    Model # 7220374 EyeSuite DICOM Option, 7220379 DICOM License .BQ 900 LED S/N: 3682  BQ LET Table S/N: 10038  BX 900 LED w/Digital EyeSuite S/N: 10016  CM 900 S/N: 354 & 491.  IM 900 / BQ 900 LED S/N: 919, 5036, 1136, 3146, 3147, 3148, 3150, 560, 3131, 2412 & 3011.  License Only S/N: 03011, 3210, BP5P922, 5617, 724, 1406, 3204, 2306, 2314, 2514, 3087, 1246, 2395 & 1063.  Lenstar S/N: 167, 285, 332, 416, 469, 656, 878, 1134, 1136, 1197, 1313, 1332, 1607, 2026, 2029, 2030, 2126, 2127, 2128, 2308, 2342, 2343, 2346, 2347, 2349, 2350, 2352, 2353, 2355, 2362, 2387, 2388, 2393, 2686, 2758, 2871, 2901, 2976, 3078, 3084, 3170, 3254, 20213, 3202, 579, 1298, 2055, 2118, 2737, 221, 485, 539, 639, 999, 1246, 2022, 2051, 2274, 2691, 2755, 2756, 2757, 2836, 2908, 3252, 3542, 3753, 3820, 3821, 3901, 3904, 3908, 3946, 3950, 20311, 20111, 20176, 20149 & 10.  Octopus 300 S/N: 4242, 3330, 3735 & 1506.  Octopus 600 S/N: 135, 246, 433, 434, 443, 708, 709, 710, 955, 956, 957, 958 & Demo.  Octopus 900 S/N: 2968, 1784, 2023, 2140, 2237, 2883, 2884, 2886, 2967, 3010, 3286, 3753, 1784, 1286, 1937, 2763, 2778, 3746, 3139, 2813, 1143, 1239, 1287, 2233, 2373, 2406, 2566, 2567, 2780, 2889, 2926, 3200, 2890, 2024, 1582, 1619, 1647, 2174, 2586, 2624, 3006, 3009, 3011 & 3372.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution.
  • Descripción del producto
    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
  • Manufacturer
    Haag-Streit USA Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall EyeSuite i.8.2.1.0 Software
Device Recall LaserEdge Knives
  • Modelo / Serial
    none
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only || Product Usage: || The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
  • Manufacturer
    Bausch & Lomb Inc Irb
  • 44 Events
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
    • Retiro De Equipo (Recall) de Device Recall LaserEdge Knives
Device Recall AMO Vitrectomy Cutter
  • Modelo / Serial
    Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
  • Descripción del producto
    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
  • Manufacturer
    Abbott Medical Optics Inc. (AMO)
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AMO Vitrectomy Cutter
Device Recall Merge Eye Care PACS Viewer 5.2
  • Modelo / Serial
    Version 5.2
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    FL, IL, CO, MI, CA, NY, ND, OH, CT
  • Descripción del producto
    Merge Eye Care PACS Viewer 5.2 || Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. || Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. || Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Eye Care PACS Viewer 5.2
Device Recall Optical Coherence Tomography System
  • Modelo / Serial
    Cat No. 700-45575 (GTIN - N/A), 700-45575-002 (GTIN - N/A), 700-45575-A (GTIN - N/A), 700-47818-001 (GTIN - N/A), 700-47818-002 (GTIN - N/A), 700-47818-003 (GTIN - N/A), 700-47818-004 (GTIN 00858848006056), 700-47827-002 (GTIN - N/A), 700-47827-004 (GTIN - N/A), 700-47827-005 (GTIN 00858848006070), 700-49007-002 (GTIN - N/A), 700-49007-003 (GTIN 00858848006216).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  • Descripción del producto
    iVue with Normative Database, Device Listing Number D185549. || Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular || structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of || retina, retinal nerve fiber layer, ganglion cell complex, and optic disc || measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
  • Manufacturer
    Optovue, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Optical Coherence Tomography System
Device Recall Optical Coherence Tomography System
  • Modelo / Serial
    Cat No. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  • Descripción del producto
    iFusion, Device Listing Number D203271. || Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and || documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND || iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior || and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of || retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
  • Manufacturer
    Optovue, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Optical Coherence Tomography System
Device Recall Optical Coherence Tomography System
  • Modelo / Serial
    Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  • Descripción del producto
    iVue 500 with iScan, D216606. || Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, || documentation, and management of ocular health and diseases in the adult population.
  • Manufacturer
    Optovue, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Optical Coherence Tomography System
Device Recall ORA System with VerifEye
  • Modelo / Serial
    Serial numbers: C5013,C5014,C5015,C5016,C5017,C5018,C5019,C5020,C5021,C5023,C5024,C5025,C5026,C5027,C5028,C5029,C5030,C5031,C5032,C5033,C5034,C5035,C5036,C5038,C5039,C5040,C5041,C5042,C5043,C5044, C5045,C5046,C5047,C5048,C5049,C5050,C5051,C5053,C5054,C5055,C5059,C5060,C5061,C5062,C5064, C5065,C5066,C5069,C5071,C5075,C5076,C5077,C5078,C5079,C5080,C5081,C5082,C5083,C5090,C5093, C5094,C5097,C5098,C5101,C5102,C5105,C5106,C5107,C5108,C5109,C5110,C5111,C5112,C5113,C5116, C5117,C5119,C5120,C5121,C5122,C5125,C5126,C5127,C5128,C5129,C5130,C5131,C5132,C5133,C5134, C5136,C5137,C5138,C5139,C5140,C5141,C5142,C5143,C5144,C5146,C5147,C5148,C5149,C5150,C5151, C5152,C5153,C5154,C5155,C5156,C5157,C5158,C5159,C5160,C5161,C5163,C5164,C5165,C5166,C5167, C5168,C5169,C5170,C5171,C5173,C5174,C5175,C5176,C5177,C5178,C5179,C5180,C5181,C5182,C5183, C5184,C5185,C5186,C5187,C5188,C5189,C5190,C5191,C5192,C5193,C5194,C5195,C5196,C5197,C5198, C5199,C5200,C5201,C5202,C5203,C5204,C5205,C5207,C5214,C5215,C5216,C5217,C5218,C5219,C5220, C5221,C5222,C5223,C5224,C5225,C5226,C5227,C5228,C5229,C5230,C5231,C5232,C5233,C5238,C5239, C5240,C5241,C5242,C5243,C5244,C5245,C5246,C5248,C5249,C5250,C5251,C5252,C5253,C5255,C5256, C5257,C5258,C5259,C5260,C5261,C5262,C5263,C5264,C5265,C5266,C5267,C5268,C5269,C5270,C5271, C5272,C5273,C5274,C5276,C5277,C5278,C5279,C5280,C5281,C5282,C5283,C5284,C5285,C5286,C5287, C5288,C5289,C5290,C5291,C5292,C5293,C5294,C5295,C5296,C5297,C5298,C5299,C5300,C5301,C5302, C5303,C5304,C5305,C5306,C5307,C5308,C5309,C5310,C5311,C5312,C5313,C5314,C5315,C5316,C5317, C5318,C5319,C5320,C5321,C5322,C5323,C5326,C5328,C5329,C5330,C5334,C5335,C5336,C5339,C5340, C5341,C5343,C5348,C5349,C5350,C5352,C5353,C5354,C5355,C5356,C5357,C5358,C5359,C5360,C5361, C5362,C5363,C5364,C5365,C5366,C5368,C5369,C5370,C5371,C5372,C5373,C5374,C5375,C5376,C5377, C5378,C5379,C5380,C5381,C5382,C5383,C5384,C5385,C5386,C5387,C5388,C5389,C5390,C5391,C5392, C5393,C5394,C5395,C5396,C5397,C5398,C5399,C5400,C5401,C5402,C5403,C5404,C5405,C5406,C5407, C5408,C5409,C5410,C5411,C5412,C5413,C5414,C5415,C5416,C5417,C5418,C5434,C5435,C5436,C5437, C5438,C5439,C5440,C5441,C5442,C5443,C5444,C5446,C5448,C5449,C5451,C5452,C5453,C5454,C5456, C5458,C5462,C5463,C5464,C5465,C5466,C5467,C5469,C5471,C5473,C5475,C5476,C5477,C5478,C5479, C5484,C5485,C5486,C5487,C5488,C5489,C5490,C5493,C5494,C5495,C5496,C5497,C5499,C5500,C5501, C5502,C5503,C5507,C5508,C5509,C5510,C5511,C5512,C5515,C5516,C5517,C5518,C5519,C5520,C5521, C5522,C5524,C5525,C5526,C5527,C5528,C5529,C5530,C5532,C5533,C5534,C5535,C5536,C5537,C5538, C5539,C5544,C5545,C5546,C5547,C5549,C5550,C5553,C5555
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom
  • Descripción del producto
    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ORA System with VerifEye
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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.