FDA-Device2021-02-24Class II
IOLMaster 700
Carl Zeiss Meditec AG
Hazard
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Sold states
U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Slovakia, Thailand, Taiwan, and South Africa.
Affected count
613 devices
Manufactured in
Carl-Zeiss-Promenade 10, N/A, Jena, N/A, Germany
Products
IOLMaster 700
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2021Don't want to check this manually?
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