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.
Check against the official notice below — it lists the full affected range.
Bausch & Lomb Inc. has recalled the Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack (model SE5420W), which contains a Stellaris Elite 20 GA Vitrectomy Cutter. The back cap can separate from the body of the vitrectomy cutter during use. A total of 9 cases were distributed across 25 U.S. states and 16 countries including Russia, Poland, France, Italy, and Thailand. The affected product has lot numbers W0862 with expiration dates of 6/4/2019 or 9/24/2019, and UDI 00757770059522.
The recall notice 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: 9 cases Lot/code info: Lot numbers W0862, exp. 6/4/2019, Exp. 9/24/2019, UDI 00757770059522.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.