Device product
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
Z-2711-2016
Product summary
- Firm
- Nidek Inc
- Event
- Event 74900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 affected devices
- Official record key
device-enforcement:Z-2711-2016
Official wording
Reason: Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
Code information: Microscopes with serial numbers: 120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044,120045, 120046, 120047, 120048, 120049, 120050.
Distribution pattern: US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
Derived failure modes
-
Unknown
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.