Oculus Pentacam AXL Wave, Ref 70020, CE 0123 recallZ-2482-2023 · Oculus Optikgeraete GMBH · initiated Aug 8, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oculus Optikgeraete GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
FDA root cause category: Process control
What the company is doing
On August 04, 2023, Oculus issued a Urgent Field Safety Notice" Correction via UPS Express. Oculus ask consignees to take the following actions: 1. Immediately stop using the affected devices for axis length measurement (mark the affected devices with a note) or take them out of service immediately. Devices not listed in Appendix B are not affected by this corrective action and can continue to be used according to the instructions for use. 2. Please fill out the attached form (Appendix A) and return it to OCULUS and your local OCULUS representative as soon as possible, but no later than 30 days after receipt. By completing this form, you acknowledge receipt of the Urgent Field Safety Notice and that you understand the issue and the actions required. 3. Pass this urgent safety information on to all users of the affected products and other people who need to be informed so that they are aware of the problem. Please file this letter directly with your device and make sure that it is and remains visible to all users at the storage location. It is important that the meaning of this notification is understood. 4. If you have given the products to a third party, please forward a copy of this information immediately and please inform us accordingly. 5. Please keep this urgent safety information at least until the action has been completed.
Recall details
- Recall number
- Z-2482-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2023
- Posted by the FDA
- Aug 30, 2023
- Recalling firm
- Oculus Optikgeraete GMBH
- Quantity
- 143 units
- Product code
- MXK
- FDA submissions
- K201724
- Distribution
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Product description
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Code information (models, lots, serial numbers)
UDI-DI; (01) 04049584025357
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pentacam AXL Wave 70020OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Device, Analysis, Anterior Segment2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92847).
- Z-2483-2023 · Open, ClassifiedOculus Pentacam AXL , Ref 70100, CE 0123
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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