Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (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. recalled the Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627) because the back cap can separate from the body of the vitrectomy cutter. A total of 94 cases were distributed across 25 U.S. states, government facilities, and 16 countries including Russia, Poland, France, and Thailand. The affected products have lot numbers W0189, W0148, W0782, W0871, W1002, W1223, and W1259, with expiration dates ranging from February 2019 to July 2019.
The recall notice does not specify a remedy or instructions for affected consumers or healthcare facilities regarding what action should be taken with the recalled product.
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: 94 cases Lot/code info: Lot numbers W0189, exp. 2/28/2019; W0148, exp. 2/26/2019; W0782, exp. 5/11/2019; W0871, exp. 6/4/2019; W1002, exp. 6/23/2019; W1223, exp. 7/21/2019; and W1259, exp. 7/27/2019, UDI 00757770059508.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.