Recall Z-1133-2021 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
Carl Zeiss Meditec AG
IOLMaster 700
| Date | Dec 7, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | On 12/11/2020, the firm sent a "FIELD SAFETY CORRECTION ACTION URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS informing them about a software error with software versions 1.90.2.09 and 1.90.8.06 that when used in conjunction with modality worklist functionality, is not performing as expected. These issues may lead to false display of patients in the patient manager screen, which can subsequently lead to the implantation of a wrong intraocular lens (IOL). The Recalling Firm is informing it customers that a software update needs to be installed on their device(s), or the modality wo |
| Quantity | 613 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, G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173771 | IOLMaster 700 Carl Zeiss Meditec, AG, Aug 24, 2018 |