Recall Z-2711-2016— Nidek Inc

Name: FDA recall Z-2711-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2016-08-08, terminated 2017-01-09. It names one FDA 510(k) clearance: K151706. 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.. 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..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2017-01-09
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K151706 — Specular Microscope CEM- 530Nidek Co., Ltd.·cleared 2016-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.