Class 2 Device Recall Oculus Pentacam AXL Wave

• Date Initiated by Firm: August 08, 2023
• Date Posted: August 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2482-2023
• Recall Event ID: 92847
• 510(K)Number: K201724
• Product Classification: Device, analysis, anterior segment - Product Code MXK
• Product: Oculus Pentacam AXL Wave, Ref 70020, CE 0123
• Code Information: UDI-DI; (01) 04049584025357
• Recalling Firm/ Manufacturer: Oculus Optikgeraete GMBH; Munchholzhauser Str. 29; Wetzlar Germany
• Manufacturer Reason for Recall: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
• FDA Determined 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 30 days after receipt. By completing this form, you acknowledge receipt of the Urgent Field Safety Notice and that you understand the issue and the actions required. 3. Pass this urgent safety information on to all users of the affected products and other people who need to be informed so that they are aware of the problem. Please file this letter directly with your device and make sure that it is and remains visible to all users at the storage location. It is important that the meaning of this notification is understood. 4. If you have given the products to a third party, please forward a copy of this information immediately and please inform us accordingly. 5. Please keep this urgent safety information at least until the action has been completed.
• Quantity in Commerce: 143 units
• Distribution: US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MXK