Home / Recalls / Medical Devices
Bausch & Lomb Inc recalls Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the em
Recalled December 26, 2012 · FDA recall Z-0593-2013 · Bausch & Lomb
Hazard
Posterior fluidics modules installed in the system may need to be recalibrated. · FDA Class II
Units
124 units
Sold at
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.
Description
Posterior fluidics modules installed in the system may need to be recalibrated.
Product
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.
Manufacturer(s)
Bausch & Lomb Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →