FDA Medical Device Recalls (openFDA)
Oculus Optikgeraete GMBH: Oculus Pentacam AXL Wave, Ref 70020, CE 0123
- Recall number
- Z-2482-2023
- Recalling firm
- Oculus Optikgeraete GMBH
- Product
- Oculus Pentacam AXL Wave, Ref 70020, CE 0123
- Status
- Open, Classified
- Initiated
- 2023-08-08
- Posted
- 2023-08-30
- Terminated
- not on file
- 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 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
- 143 units
- Distribution
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
- Lot, serial or model codes
- UDI-DI; (01) 04049584025357
- 510(k) numbers
- ["K201724"]
- PMA numbers
- not on file
- Product code
- MXK
- Firm FEI
- 3002807782
- Firm city
- Wetzlar
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28