Z-2484-2023Class II

Oculus Myopia Master , Ref 68100, CE 0123

Name: Z-2484-2023 Oculus Myopia Master , Ref 68100, CE 0123
Creator: Oculus Optikgeraete GMBH
Published: 2023-08-08
License: https://open.fda.gov/license/

Oculus Optikgerate GmbH / initiated 2023-08-08 / Open, Classified / root cause: manufacturing process

FDA source

Oculus Optikgeraete GMBH began a recall of Oculus Myopia Master , Ref 68100, CE 0123 on 2023-08-08. FDA classified it as Class II and gives the reason as "Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2484-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2023-08-30
Recalling firm: Oculus Optikgerate GmbH
Product: Oculus Myopia Master , Ref 68100, CE 0123
Product code: MXK Device, Analysis, Anterior Segment
Reason for recall: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: UDI-DI; (01) 04049584026095

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2484-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2482-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30
Z-2483-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30
Z-2484-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30

Product code MXK

K202989Class IIMyopia MasterOculus Optikgeräte GmbH / cleared 2021-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)