FDA (Devices) recall action 77823
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Alcon is recalling 367 ORA Systems with VerifEye because a software error may cause incorrect intraocular lens power measurements during cataract surgery.
Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.