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Recall Observatory FDA recall evidence

Device product

IOLMaster 700

Z-1133-2021

December 07, 2020

Class II

Product summary

Firm
Carl Zeiss Meditec AG
Event
Event 87055
Status
Terminated
Classification
Class II
Quantity
613 devices
Official record key
device-enforcement:Z-1133-2021

Official wording

Reason: 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

Code information: Model: IOLMaster 700 Catalog Number device: 000000-1932-169

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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