Phoroptor VRx Digital Refraction System Model Numbers: 16241
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2025