FDA Device recall Z-2483-2023
Oculus Pentacam AXL , Ref 70100, CE 0123
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Oculus Pentacam AXL , Ref 70100, CE 0123 by Oculus Optikgeraete, citing their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2483-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-08 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oculus Optikgeraete |
| Distribution | US |
Product
Oculus Pentacam AXL , Ref 70100, CE 0123
Reason
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Identifiers
| code_info | UDI-DI; (01) 04049584012333 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2483-2023%22
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