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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Alcon Research, Ltd.: Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.

Agency Publication Date: August 21, 2017
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Affected Products

Product: ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

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

Product: ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77823
Status: Resolved
Manufacturer: Alcon Research, Ltd.
Manufactured In: United States
Units Affected: 2 products (429 units; 367 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.