Carl Zeiss Meditec AG recalls IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of

Recalled December 9, 2015 · FDA recall Z-0358-2016 · Carl Zeiss Meditec AG

Hazard

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. · FDA Class II

Units

1882

Sold at

Nationwide Distribution.

Description

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

Product

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

Manufacturer(s)

Carl Zeiss Meditec AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →