Carl Zeiss Meditec AG recalls IOLMaster 700

Recall date

December 7, 2020

Source

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

Recall number

Z-1133-2021

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec AG

Sold / distributed

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, G…

Why it was recalled

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

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

What was recalled

IOLMaster 700