FDA (Devices) recall action 90661
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
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.
Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.
A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.
A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.