b03877d4-c77e-4114-9275-96ebb589c6bfNewPublished12022-12-092022-12-01In Commercial Distribution00078041131663PrimaryGS1ICU Eyewear60304106001952241ZOOM EYEWORKS DBA ICU EYEWEAR, INC.1falsetruefalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue46297Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).falseActive42832Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.falseActiveHQYSunglasses (non-prescription including photosensitive)HOISpectacle, magnifyingfalsefalse