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Carl Zeiss Meditec AG Recall 87055

Description: IOLMaster 700

Carl Zeiss Meditec AG Recall 87055 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1133-2021
Event ID87055
Event DescriptionIOLMaster 700
Product TypeDevices
DistributionU.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.
Quantity613 devices
Recall ReasonWhen 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
Device Classification20210224
Device Code InfoModel: IOLMaster 700 Catalog Number device: 000000-1932-169
Center Classification Date20210218
Recall Initiation Date20201207
Recalling FirmCarl Zeiss Meditec AG
Initial Notification Letter
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