Johnson & Johnson Surgical Vision Inc: Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicate

Is my product affected?

Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction.

• UPC 05050474558458
• UPC 05050474558076
• UPC 05050474558090
• UPC 05050474558106
• UPC 05050474558113
• UPC 05050474558120
• UPC 05050474558137
• UPC 05050474558144
• UPC 05050474558151
• UPC 05050474558175
• UPC 05050474558410
• UPC 05050474558434
• UPC 05050474558441
• UPC 05050474558465

Check against the official notice below — it lists the full affected range.

What happened

Johnson & Johnson Surgical Vision Inc. distributed 17 expired Abbott TECNIS 1-Piece Aspheric Acrylic intraocular lenses (IOLs) with TECNIS iTEC Preloaded Delivery System, model PCB00. The lenses were distributed nationwide in Indiana, Minnesota, North Carolina, Nevada, Texas, Washington, and West Virginia. The affected lenses had various power ratings ranging from 10.5D to 29.5D, with expiration dates between February 3, 2018 and May 11, 2018.

The record does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Expired intraocular lenses were distributed.

Details from the source

Reason for recall: Expired intraocular lenses were distributed. Distribution: US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution. Quantity: 17 IOL's Lot/code info: Item PCB00 29.5D, Ser. #3496431503, exp. 3/11/2018, UDI (01)05050474558458(17)180311(21)3496431503; Item PCB00 10.5D, Ser. #4824531411, exp. 10/9/2017, UDI (01)05050474558076(17)171009(21)4824531411; Item PCB00 11.5D, Ser. #2354451505, exp. 5/7/2018, UDI (01)05050474558090(17)180507(21)2354451505; Item PCB00 12.0D, Ser. #3595511502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595511502; Item PCB00 12.0D, Ser. #3595551502, exp. 2/14/2018, UDI (01)05050474558106(17)180214(21)3595551502; Item PCB00 12.5D, Ser. #3488131502, exp. 2/13/2018, UDI (01)05050474558113(17)180213(21)3488131502; Item PCB00 13.0D, Ser. #5435161502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435161502; Item PCB00 13.0D, Ser. #5435261502, exp. 2/26/2018, UDI (01)05050474558120(17)180226(21)5435261502; Item PCB00 13.5D, Ser. #3004621502, exp. 2/10/2018, UDI (01)05050474558137(17)180210(21)3004621502; Item PCB00 14.0D, Ser. #3242641504, exp. 4/13/2018, UDI (01)05050474558144(17)180413(21)3242641504; Item PCB00 14.0D, Ser. #6356451503, exp. 3/31/2018, UDI (01)05050474558144(17)180331(21)6356451503; Item PCB00 14.5D, Ser. #2212331502, exp. 2/3/2018, UDI (01)05050474558151(17)180203(21)2212331502; Item PCB00 15.5D, Ser. #2577541505, exp. 5/11/2018, UDI (01)05050474558175(17)180511(21)2577541505; Item PCB00 27.5D, Ser. #2173131504, exp. 4/2/2018, UDI (01)05050474558410(17)180402(21)2173131504; Item PCB00 28.5D, Ser. #3526291503, exp. 3/11/2018, UDI (01)05050474558434(17)180311(21)3526291503; Ite

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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