Z-1133-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- December 7, 2020
- Termination Date
- June 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 613 devices
Product Description
IOLMaster 700
Reason for Recall
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
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.
Code Information
Model: IOLMaster 700 Catalog Number device: 000000-1932-169