FDA-Device2015-12-09Class II
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.
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.
Sold states
Nationwide Distribution.
Affected count
1882
Manufactured in
Carl Zeiss Promenade 10, Jena, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0358-2016Don't want to check this manually?
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