Recall Z-2482-2023 ยท MXK Device, Analysis, Anterior Segment
Oculus Optikgeraete GMBH
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
| Date | Aug 30, 2023 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| Root cause | Process control |
| Action | On August 04, 2023, Oculus issued a Urgent Field Safety Notice" Correction via UPS Express. Oculus ask consignees to take the following actions: 1. Immediately stop using the affected devices for axis length measurement (mark the affected devices with a note) or take them out of service immediately. Devices not listed in Appendix B are not affected by this corrective action and can continue to be used according to the instructions for use. 2. Please fill out the attached form (Appendix A) and return it to OCULUS and your local OCULUS representative as soon as possible, but no later than 3 |
| Quantity | 143 units |
| Distribution | US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201724 | Pentacam AXL Wave Oculus Optikgerate GmbH, Oct 21, 2020 |