Oculus Pentacam AXL Wave, Ref 70020, CE 0123

FDA device recall Z-2482-2023 · posted 2023-08-30 · Open, Classified

Recall details

Recalling firm

Oculus Optikgeraete GMBH

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

MXK

Quantity affected

143 units

Distribution

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

Date initiated

2023-08-08

Date posted

2023-08-30

Location

Wetzlar, Germany

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