Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (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 is recalling the Stellaris Elite Vision Enhancement System 20 ga. Posterior Mid-Field Elite Pack, which contains a vitrectomy cutter (Model BL5626). The back cap on the cutter can separate from the body of the device. The affected product was distributed in 16 cases across 25 U.S. states and to 15 countries including Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Great Britain, France, Spain, Singapore, Malaysia, and Thailand. The recalled lot numbers are W0861 (expiration 6/4/2019) and W1115 (expiration 7/5/2019).
The FDA recall record does not specify a remedy or what consumers should do regarding 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: 16 cases Lot/code info: Lot numbers W0861, Exp. 6/4/2019, and W1115, exp. 7/5/2019, UDI 00757770059447.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.