FDA-Device2018-10-03Class II
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Bausch & Lomb Inc
Hazard
The back cap separates from the body of the vitrectomy cutter.
Sold states
Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
Affected count
131 cases
Manufactured in
3365 Tree Court Industrial Blvd, Saint Louis, MO, United States
Products
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3271-2018Don't want to check this manually?
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