Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (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 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack (model SE5423MV, containing the 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 across 25 U.S. states and to 16 countries including Russia, Poland, France, Italy, Israel, Thailand, and Malaysia. The recall involved 19.33 cases with lot numbers W0147, W0781, W0870, and W1721, with expiration dates ranging from February 2019 to October 2019.
The product identification number is UDI 00757770059423. The recall source does not specify what remedy affected consumers should pursue.
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: 19.33 cases Lot/code info: Lot numbers W0147, exp. 2/26/2019; W0781, exp. 5/11/2019; W0870, exp. 6/4/2019; and W1721, 10/1/2019, UDI 00757770059423.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.