Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), 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, 25 ga. Posterior Mid-Field Elite Pack (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628) because the back cap can separate from the body of the vitrectomy cutter. A total of 67 cases were distributed across 25 U.S. states, to government facilities, and to 16 countries including Russia, France, Italy, Israel, and Thailand. The affected product includes five lot numbers: W0149 (expiration 2/26/2019), W0190 (2/28/2019), W0785 (5/11/2019), W0874 (6/4/2019), and W1108 (7/5/2019), with UDI 00757770059430.
The source record does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
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: 67 cases Lot/code info: Lot numbers W0149, exp. 2/26/2019; W0190, exp. 2/28/2019; W0785, exp. 5/11/2019; W0874, exp. 6/4/2019; and W1108, exp. 7/5/2019, UDI 00757770059430.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.