Oculus Myopia Master optical device recalled for insufficient anti-reflective coating
Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where measurement errors could affect clinical outcomes. No illnesses or injuries have been reported, but the coating deficiency could lead to diagnostic errors in optical assessments. The FDA Class II classification and absence of reported harm place this in the High severity category.
Plain-English summary
The Oculus Myopia Master (Ref 68100, CE 0123), manufactured by Oculus Optikgeraete GMBH, is being recalled. The recall affects 173 units distributed nationwide in the United States.
Some devices may have insufficient anti-reflective coating on their optical surfaces. This deficiency could result in incorrect axial length measurements, which could impact the accuracy of optical assessments performed with the device.
The recalled devices were distributed in California, Florida, Massachusetts, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and Washington. Healthcare facilities using this device should identify affected units by the UDI-DI 04049584026095 and contact the manufacturer for instructions on replacement or repair.
The recalled product
- Product
- Oculus Myopia Master , Ref 68100, CE 0123
- Manufacturer
- Oculus Optikgeraete GMBH
- Hazard
- measurement-error
- coating-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI
- (01) 04049584026095
Distribution
Distributed nationwide across the United States.
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