Oculus recalls Pentacam AXL Wave devices with insufficient anti-reflective coating that may cause incorrect axial length measurements. Affected units include Ref 70020, CE 0123 models sold with UDI-DI (01) 04049584025357.
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Oculus is recalling Pentacam AXL Wave devices that may give incorrect axial length measurements due to insufficient anti-reflective coating. This could affect eye measurements used in certain medical procedures. The recall is for specific model numbers and serial codes.
The device may have insufficient anti-reflective coating, which can lead to incorrect axial length measurements. Incorrect measurements could impact medical decisions related to eye health. This is a technical issue with the device's optics.
Users of the Oculus Pentacam AXL Wave device with Ref 70020 and CE 0123 models are affected. Medical professionals using the device for eye measurements are most at risk.
Check for the model reference 'Ref 70020' and CE marking '0123' on the device. The unique identifier (UDI-DI) is (01) 04049584025357 for affected units.
Verify the model reference and CE marking on your device to confirm if it is affected.
The affected model is Oculus Pentacam AXL Wave with reference number Ref 70020 and CE marking 0123.
Incorrect axial length measurements could impact medical decisions related to eye health, but the recall does not specify immediate health risks.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Oculus to request your refund or repair — edit it as you like.
Subject: Recall Z-2482-2023 — Oculus Oculus Hello, I own a Oculus that is covered by recall Z-2482-2023 from Oculus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.