FDAFDA · Food and drugs·Recall number Z-2711-2016
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.
Published September 7, 2016 · Recall initiated: August 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nidek Inc
- Distributor
- US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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