FDAFDA · Food and drugs·Recall number Z-2483-2023
Oculus Pentacam AXL , Ref 70100, CE 0123
Published September 6, 2023 · Recall initiated: August 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Oculus Optikgeraete GMBH
- Distributor
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
- Lot
- UDI-DI; (01) 04049584012333
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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