OPTICAL BIOMETER AL-Scan: Software Version: 1 — Class II medical device recall Z-2587-2016
Terminated recall by Nidek Inc, reported 2016-08-24, distributed nationwide. Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much s
| Recall number | Z-2587-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 17 |
| Serial numbers | 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036 |
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 for recall
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2587-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.