Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (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 is recalling the Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack (model SE5525WV, containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628) because the back cap can separate from the body of the vitrectomy cutter. The recalled product consists of 10 cases with lot number W0788, expiration date 5/11/2019, and UDI 00757770059683. Distribution included multiple U.S. states and numerous countries including Russia, Romania, Poland, the Netherlands, Italy, France, Spain, and Thailand, as well as government distribution within the United States.
The record does not specify a remedy or recommended action for affected consumers.
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: 10 cases Lot/code info: Lot number W0788, exp. 5/11/2019, UDI 00757770059683.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.