ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Check against the official notice below — it lists the full affected range.
Carl Zeiss Meditec AG is recalling 1,225 ZEISS miLOOP Lens Fragmentation Devices (Model 303071-9090-000, Catalog Number FG-50608) used during cataract surgery. The devices have a safety issue where high friction in the slider can cause it to stick or fail to move as intended during the procedure.
The affected devices were distributed across 34 U.S. states and Puerto Rico. The recall involves Lot Number FG21082410 with UDI (01)04049539104496(11)201102(17)231031(10)FG21082410. The source does not specify what remedy is available to consumers or what actions they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
High friction of the slider can cause the device to stick, or not move as intended.
Reason for recall: High friction of the slider can cause the device to stick, or not move as intended. Distribution: U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided Quantity: 1225 devices Lot/code info: Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.