FDA Device recall Z-2587-2016
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier by Nidek, citing nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2587-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-01 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nidek |
| Distribution | US |
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.
Identifiers
| code_info | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class III · 2020-01-08 · Nidek - RT-5100 Refractor, a component of the Epic-5100 System
FDA Device · Class III · 2018-12-26 · Nidek - AUTO REF/KERATOMETER ARK-1s
FDA Device · Class II · 2018-04-18 · Nidek - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2587-2016%22
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