Recall Z-3050-2017
Alcon Research, Ltd. · initiated June 30, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Codes / lots: 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,C4189…
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.
FDA-determined cause: Software design
Action taken
The Market Action was initiated with Initial telephone contact to all affected customers starting June 30, 2017. These customers were informed of the issue, and advised not to use their ORA Carts for calculations with the lens model affected on their specific system. A confirmatory letter (Attachment 4) was also sent via overnight mail to these customers July 12, 2017. As of July 12, 2017, Alcon has identified 8 ORA Carts that are affected by the software coding error. Alcon has reset the IOL databases on all 8 of the identified affected ORA Carts.
Details
- Recall number
- Z-3050-2017
- Initiated
- June 30, 2017
- Terminated
- August 27, 2019
- Product code
- NCF – Aberrometer, Ophthalmic
- Quantity
- 367 units
- 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
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3049-2017 Class II | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular…Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This… | 06/30/2017Terminated |