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 oc…

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0358-2016

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec AG

Sold / distributed

Nationwide Distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.