Medical device recalls Moderate risk

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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