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Carl Zeiss Meditec AG recalls IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculation
Recalled December 9, 2015 · FDA recall Z-0357-2016 · 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
49
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 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.
Manufacturer(s)
Carl Zeiss Meditec AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →