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Bausch & Lomb Inc recalls Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing
Recalled October 3, 2018 · FDA recall Z-3276-2018 · Bausch & Lomb
Hazard
The back cap separates from the body of the vitrectomy cutter. · FDA Class II
Units
66 cases
Sold at
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.
Description
The back cap separates from the body of the vitrectomy cutter.
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
Manufacturer(s)
Bausch & Lomb Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →