Devices

Device Recall ORA System with VerifEye

  • Modèle / numéro de série
    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
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event

Fabricant

Alcon Research, Ltd.
  • Adresse du fabricant
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    USFDA

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Device Recall ORA System with VerifEye
  • Modèle / numéro de série
    Serial Numbers: C0002,C2006,C2020,C2026,C2054,C3009R,C3010R,C3024,C3036,C3066,C3067,C3085R,C3090,C3093,C3108,C3136,C3153,C4001,C4003,C4005,C4006,C4007,C4009,C4010,C4011,C4012,C4013,C4014,C4015,C4016,C4017,C4019,C4020,C4021,C4022,C4023,C4024,C4025,C4026,C4027,C4028,C4029,C4030,C4031,C4035,C4036,C4037,C4038,C4039,C4040,C4043,C4045,C4046R,C4047R,C4049R,C4050R,C4052R,C4053R,C4054R,C4055R,C4056R,C4057R,C4058R,C4059R,C4060R,C4061R,C4062R,C4065R,C4066R,C4067R,C4068R,C4069R,C4070R,C4071R,C4072R,C4073R,C4074R,C4075R,C4076R,C4077R,C4078R,C4079R,C4080R,C4083R,C4085R,C4086R,C4087RC4088R,C4089R,C4090R,C4091R,C4092R,C4093R,C4094R,C4095R,C4096R,C4097R,C4098R,C4099R,C4100R,C4101R,C4102R,C4103R,C4104R,C4105R,C4106R,C4107R,C4108R,C4109R,C4110R,C4111R,C4112R,C4113R,C4115R,C4117R,C4118R,C4119R,C4120R,C4121R,C4122R,C4123R,C4124R,C4126R,C4127R,C4128R,C4129R,C4130R,C4132R,C4133R,C4134R,C4135R,C4136R,C4138R,C4140,C4142,C4143,C4144,C4145,C4146,C4147,C4148,C4149,C4150,C4151,C4152R,C4153,C4154,C4155,C4156,C4157R,C4158,C4159,C4160R,C4161R,C4162R,C4163R,C4164R,C4165R,C4166R,C4167R,C4168R,C4169R,C4170R,C4173R,C4174R,C4175,C4177R,C4178R,C4179R,C4180R,C4181R,C4182R,C4183R,C4184R,C4185R,C4186R,C4187R,C4188R,C4189R,C4190R,C4191R,C4192R,C4193R,C4195R,C4196R,C4197R,C4198,C4199R,C4200R,C4201,C4202R,C4203R,C4204R,C4205R,C4206R,C4207R,C4208R,C4209R,C4210R,C4211R,C4212R,C4213R,C4214R,C4215R,C4216R,C4217R,C4218R,C4219R,C4220R,C4221R,C4222R,C4223R,C4224R,C4225R,C4226R,C4227R,C4228R,C4229R,C4230R,C4231R,C4232R,C4233R,C4234R,C4235R,C4238R,C4239R,C4240R,C4241R,C4242R,C4243R,C4244R,C4245R,C4246R,C4247R,C4248R,C4249R,C4251R,C4252R,C4253R,C4254R,C4255R,C4256R,C4257R,C4258R,C4259R,C4260R,C4261R,C4262R,C4264R,C4266R,C4267R,C4268R,C4269R,C4271R,C4272R,C4273R,C4274R,C4275R,C4276R,C4278R,C4279R,C4280R,C4283R,C4284R,C4285R,C4286R,C4287R,C4288R,C4289R,C4290R,C4291R,C4292R,C4293R,C4294R,C4295R,C4296R,C4297R,C4298R,C4299R,C4300R,C4301R,C4302R,C4303R,C4304R,C4305R,C4306R,C4307R,C4308R,C4309R,C4310R,C4311R,C4312R,C4315R,C4316R,C4317R,C4318R,C4319R,C4320R,C4321R,C4323R,C4324R,C4326R,C4327R,C4328R,C4331R,C4332R,C4334R,C4337R,C4339R,C4340R,C4341R,C4342R,C4343R,C4344R,C4345R,C4346R,C4347R,C4348R,C4349R,C4352R,C4354R,C4355R,C4356R,C4357R,C4358R,C4359R,C4360R,C4361R,C4363R,C4364R,C4365R,C4366R,C4367R,C4368R,C4371R,C4372R,C4373R,C4374R,C4376R,C4377R,C4378R,C4379R,C4380R,C4381R,C4382R,C4383R,C4384R,C4385R,C4387R,C4388R,C4389R,C4394,C4396,C4397,C4399,C4406R,C4407R,C4408R,C4415,C4418,C4420,C4421,C4422,C4423,C4424,C4425,C4426
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
  • Manufacturer
    Alcon Research, Ltd.