Oculus Optikgeraete GMBH 2023-09-06 Health serious FDA
Health · FDA · Recall #FDA-Z-2483-2023
Oculus Pentacam AXL , Ref 70100, CE 0123 Recall
Issued September 6, 2023 · Oculus Optikgeraete GMBH
In September 2023, Oculus Optikgeraete GMBH recalled the Oculus Pentacam AXL , Ref 70100, CE 0123, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
What you should do
- 1 Stop using Oculus Pentacam AXL , Ref 70100, CE 0123 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Oculus Optikgeraete GMBH to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Oculus Optikgeraete GMBH
- Category
- Health
- Recall date
- September 6, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
- Recall number
- FDA-Z-2483-2023
- Made in
- Germany
- Issuing agency
- FDA
In context
- Oculus Optikgeraete GMBH has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.