FDAClass IISeptember 6, 2023

Oculus Pentacam AXL Wave recall

Oculus Pentacam AXL Wave, Ref 70020, CE 0123

Why was Oculus Pentacam AXL Wave recalled?

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI; (01) 04049584025357

Product
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Recalling firm
Oculus Optikgeraete GMBH
Quantity
143 units
Distribution
US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Recall date
September 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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