Z-2587-2016 Class II Terminated
FDA device recall Z-2587-2016 was initiated by Nidek Inc on July 1, 2016 and is designated Class II. 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. The recall status is terminated (terminated December 22, 2016). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- July 1, 2016
- Termination Date
- December 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Distribution Pattern
US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
Code Information
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.