Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
Check against the official notice below — it lists the full affected range.
Bausch & Lomb Inc. is recalling the Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack (Model SE5523MV, containing Stellaris Elite 23 GA Vit Cutter Model BL5627) because the back cap can separate from the body of the vitrectomy cutter. The affected product was distributed to 25 U.S. states, various international locations including European countries, Middle Eastern countries, and Asian countries, with a total of 39.33 cases recalled. The specific lot numbers involved are W0783 (expiration 5/11/2019), W0872 (expiration 6/4/2019), W1107 (expiration 7/5/2019), and W1224 (expiration 7/21/2019), with UDI 00757770059454.
The recall record does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The back cap separates from the body of the vitrectomy cutter.
Reason for recall: The back cap separates from the body of the vitrectomy cutter. Distribution: 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 Quantity: 39.33 cases Lot/code info: Lot numbers W0783, exp. 5/11/2019; W0872, exp 6/4/2019; W1107, exp. 7/5/2019; and W1224, exp. 7/21/2019; UDI 00757770059454.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.