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

Class I - Dangerous

🏥 Medical Devices Recalled: June 30, 2017 Alcon Research Other Medical Devices Nationwide

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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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Alcon Research, Ltd.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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