FDA-Device2023-09-06Class II
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Oculus Optikgeraete GMBH
Hazard
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Sold states
US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Affected count
143 units
Manufactured in
Munchholzhauser Str. 29, N/A, Wetzlar, N/A, Germany
Products
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2023Don't want to check this manually?
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