FDA Enforcement
Class II
Ongoing
Oculus Pentacam AXL , Ref 70100, CE 0123
Recall: Z-2483-2023
·
Reported September 6, 2023
Enforcement
- Recall Number
- Z-2483-2023
- Event ID
- 92847
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oculus Optikgeraete GMBH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 6, 2023
- Initiation Date
- August 8, 2023
- Classification Date
- August 30, 2023
- Address
- Munchholzhauser Str. 29, N/A, Wetzlar, N/A, N/A, Germany
Description
Oculus Pentacam AXL , Ref 70100, CE 0123
Reason
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Code Info
UDI-DI; (01) 04049584012333
Distribution
US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Quantity
364 units