Reported Aug 24, 2016 · Terminated
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- OPTICAL BIOMETER AL-ScanSoftware
- Version1.09 and earlier
- OphthalmicThe 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
- Lot codes and dates
- OPTICAL BIOMETER AL-ScanSoftware
- Version1.09 and earlier
- Serial numbers
220005220006220008220009220013220017220018220019220020220021220023220025220026220031220032220033220036
- Amount recalled
- 17
Where it was sold
Why it was recalled
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
This product could cause temporary or reversible health problems — stop using it.
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