Bausch & Lomb Inc recalls Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing

Recalled October 3, 2018 · FDA recall Z-3267-2018 · Bausch & Lomb

Hazard

The back cap separates from the body of the vitrectomy cutter. · FDA Class II

Units

9 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, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), 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 →