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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Oculus Optikgeraete GMBH: Oculus Diagnostic Devices Recalled for Potential Incorrect Eye Measurements

Agency Publication Date: August 30, 2023
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Summary

Oculus Optikgeraete GMBH is recalling approximately 680 units of its Pentacam AXL Wave, Pentacam AXL, and Myopia Master optical diagnostic devices because they may have an insufficient anti-reflective coating. This defect can lead to incorrect axial length measurements of the eye, which are critical for clinical diagnosis and treatment planning. The affected units include model references 70020, 70100, and 68100, and were distributed across 11 U.S. states. Consumers should contact their healthcare provider or the manufacturer to determine if their specific device requires service.

Risk

The insufficient coating on the optical components may cause internal reflections that distort measurements of the eye's length. This could result in incorrect medical diagnoses or the selection of improper corrective lens powers for patients.

What You Should Do

  1. Identify if your facility uses the Oculus Pentacam AXL Wave (Ref 70020, UDI-DI 04049584025357), Oculus Pentacam AXL (Ref 70100, UDI-DI 04049584012333), or Oculus Myopia Master (Ref 68100, UDI-DI 04049584026095).
  2. Check the manufacturer's notification letter for specific serial numbers or contact your Oculus representative to confirm if your specific unit is part of the 680 affected devices.
  3. If you are a patient who recently had eye measurements taken with these devices, contact your healthcare provider to discuss whether measurements need to be verified or repeated.
  4. Healthcare facilities should contact Oculus Optikgeraete GMBH at Munchholzhauser Str. 29, Wetzlar, Germany, or through their local distributor for further instructions regarding device testing or replacement.
  5. Contact the FDA Food and Drug Administration at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Potential device repair or replacement due to coating defect.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Oculus Pentacam AXL Wave
Model / REF:
Ref 70020
Z-2482-2023
Lot Numbers:
UDI-DI; (01) 04049584025357
Product: Oculus Pentacam AXL
Model / REF:
Ref 70100
Z-2483-2023
Lot Numbers:
UDI-DI; (01) 04049584012333
Product: Oculus Myopia Master
Model / REF:
Ref 68100
Z-2484-2023
Lot Numbers:
UDI-DI; (01) 04049584026095

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92847
Status: Active
Manufacturer: Oculus Optikgeraete GMBH
Sold By: Authorized Medical Device Distributors
Manufactured In: Germany
Units Affected: 3 products (143 units; 364 units; 173 units)
Distributed To: California, Florida, Massachusetts, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.