Agency classClass IIOur severity:High FDA (Devices)·Z-2484-2023·Announced 2023-09-06

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Optical Measurement Device
Hazard: measurement-error
coating-deficiency
Affected units: 173

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.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Oculus Optikgeraete GMBH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Oculus Optikgeraete GMBH

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