Recall Z-2587-2016— Nidek Inc

Name: FDA recall Z-2587-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2016-07-01, terminated 2016-12-22. It names one FDA 510(k) clearance: K133132. Product: OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.. Reason: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2016-12-22
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133132 — OPTICAL BIOMETER AL-SCANNidek Co., Ltd.·cleared 2014-06-11

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

OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

Reason for recall

Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

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