FDA-Device2012-12-26Class II
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Bausch & Lomb Inc
Hazard
Posterior fluidics modules installed in the system may need to be recalibrated.
Sold states
Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon. There was no government or military distribution.
Affected count
124 units
Manufactured in
1400 North Goodman Street, Rochester, NY, United States
Products
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0593-2013Don't want to check this manually?
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