Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (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. Combined Mid-Field Elite Pack (model SE5525MV) because the back cap can separate from the body of the vitrectomy cutter. A total of 66 cases were distributed across 25 U.S. states, government facilities, and 15 countries including Russia, Romania, Poland, the Netherlands, Israel, France, Spain, and Thailand. The affected product includes lot numbers W0787 (expiration 5/11/2019), W0888 (expiration 6/4/2019), W1003 (expiration 6/23/2019), and W1129 (expiration 7/6/2019), with UDI 00757770059430.
The recall record does not specify any remedy or actions that affected consumers 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: 66 cases Lot/code info: Lot numbers W0787, exp. 5/11/2019; W0888, exp. 6/4/2019; W1003, exp. 6/23/2019; and W1129, exp 7/6/2019, UDI 00757770059430.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.