Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), 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, 23 ga. Combined Wide-Field Elite Pack (REF SE5523WV) because the back cap can separate from the body of the vitrectomy cutter. The affected product consists of 15.33 cases with lot numbers W0784 (expiration 5/11/2019) and W0873 (expiration 6/4/2019), identified by UDI 00757770059690.
The recalled product was distributed to hospitals and healthcare facilities across 25 U.S. states including California, Florida, New York, and Texas, as well as to 16 countries including France, Germany, Italy, and others. The source document does not specify what consumers or users should do 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: 15.33 cases Lot/code info: Lot numbers W0784, exp, 5/11/2019, and W0873, exp. 6/4/2019, UDI 00757770059690.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.