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U.S. Department of Health and Human Services

Class 2 Device Recall Oculus Myopia Master

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  Class 2 Device Recall Oculus Myopia Master see related information
Date Initiated by Firm August 08, 2023
Date Posted August 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-2484-2023
Recall Event ID 92847
510(K)Number K202989  
Product Classification Device, analysis, anterior segment - Product Code MXK
Product Oculus Myopia Master , Ref 68100, CE 0123
Code Information UDI-DI; (01) 04049584026095
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 2		 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 173 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 and Original Applicant = OCULUS Optikgeräte GmbH
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