FDA-Device2023-09-06Class II
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].
Reichert, Inc.
Hazard
Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
Sold states
US Nationwide distribution.
Affected count
53 units; Extended 34 units
Manufactured in
3362 Walden Ave, N/A, Depew, NY, United States
Products
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2512-2023Don't want to check this manually?
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