Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL Wave, Ref 70020, CE 0123
- Recall date
- August 8, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2482-2023
- FDA classification
- Class II
- Brand / firm
- Oculus Optikgeraete GMBH
- Sold / distributed
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Why it was recalled
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
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