FDA (Devices) recall action 72564
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.
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
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.
Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.
Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.