FDA-Device2015-12-09Class II
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
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
49
Manufactured in
Carl Zeiss Promenade 10, Jena, Germany
Products
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief