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Nidek Inc recalls OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring
Recalled August 24, 2016 · FDA recall Z-2587-2016 · Nidek
Hazard
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. · FDA Class II
Units
17
Sold at
US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
Description
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →