Oculus Pentacam AXL Wave — Class II medical device recall Z-2482-2023
Ongoing recall by Oculus Optikgeraete GMBH, reported 2023-09-06, distributed nationwide. Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axia
| Recall number | Z-2482-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oculus Optikgeraete GMBH, Wetzlar, N/A, Germany |
| Recall initiated | 2023-08-08 |
| Classified | 2023-08-30 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 143 units |
| UPC / GTIN / UDI-DI | 04049584025357 |
| Model numbers | 0123, 70020 |
Product
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Reason for recall
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
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-2482-2023. 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.