Recall Z-3050-2017 ยท NCF Aberrometer, Ophthalmic
Alcon Research, Ltd.
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
| Date | Jun 30, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.