Carl Zeiss Meditec AG Recall 87055
Description: IOLMaster 700
Carl Zeiss Meditec AG Recall 87055 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1133-2021 |
| Event ID | 87055 |
| Event Description | IOLMaster 700 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 613 devices |
| Recall 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 |
| Device Classification | 20210224 |
| Device Code Info | Model: IOLMaster 700 Catalog Number device: 000000-1932-169 |
| Center Classification Date | 20210218 |
| Recall Initiation Date | 20201207 |
| Recalling Firm | Carl Zeiss Meditec AG |
| Initial Notification | Letter |
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