Oculus Optikgeraete GMBH Recall 92847
Description: Oculus Pentacam AXL , Ref 70100, CE 0123
Oculus Optikgeraete GMBH Recall 92847 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2483-2023 |
| Event ID | 92847 |
| Event Description | Oculus Pentacam AXL , Ref 70100, CE 0123 |
| Product Type | Devices |
| 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 |
| Recall Reason | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| Device Classification | 20230906 |
| Device Code Info | UDI-DI; (01) 04049584012333 |
| Center Classification Date | 20230830 |
| Recall Initiation Date | 20230808 |
| Recalling Firm | Oculus Optikgeraete GMBH |
| Initial Notification | Letter |
| Similar To |