FDAAugust 8, 2023device
Oculus Pentacam AXL , Ref 70100, CE 0123
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
What to do
FDA enforcement status: Ongoing
Brands named
oculus optikgeraeteoculus
UPCs
04049584012333
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhaseOne Antimicrobial Solution, Model/Catalog Number: 150502026-04-27
- FDAOculus Myopia Master , Ref 68100, CE 01232023-08-08
- FDAOculus Pentacam AXL Wave, Ref 70020, CE 01232023-08-08
- FDAPentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.2022-07-08
- FDAPentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
- FDAPentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
- FDAOCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, a...2017-11-21
- FDACeramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses incl...2016-11-21
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