Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (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. is recalling the Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack (model SE5425WV, containing vitrectomy cutter model BL5628) because the back cap can separate from the body of the vitrectomy cutter. The affected product was distributed to 25 U.S. states and to government facilities, as well as to 15 countries internationally. The recall involves approximately 97.33 cases across five specific lot numbers with expiration dates ranging from February 2019 to July 2019.
The recall notice does not specify a remedy for consumers or healthcare facilities who have received this 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: 97.33 cases Lot/code info: Lot numbers W0157, exp. 2/26/2019; W0191, exp. 2/28/2019; W0786, exp. 5/11/2019; W1116, exp. 7/5/2019; and W1225, exp. 7/21/2019, UDI 00757770059485.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.