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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3050-2017

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

Publicado el 30 de agosto de 2017 · Inicio del retiro: 30 de junio de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Telephone

Detalles del retiro

Fabricante
Alcon Research, Ltd.
Distribuidor
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
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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