Device product
Oculus Pentacam AXL , Ref 70100, CE 0123
Z-2483-2023
Product summary
- Event
- Event 92847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 364 units
- Official record key
device-enforcement:Z-2483-2023
Official wording
Reason: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Code information: UDI-DI; (01) 04049584012333
Distribution pattern: US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Derived failure modes
-
Unknown
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.