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Johnson & Johnson Surgical Vision Inc recalls Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx
Recalled November 21, 2018 · FDA recall Z-0464-2019 · Johnson & Johnson Surgical Vision
Hazard
Expired intraocular lenses were distributed. · FDA Class II
Units
17 IOL's
Sold at
US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
Description
Expired intraocular lenses were distributed.
Product
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. These devices are intended to be placed in the capsular bag.
Manufacturer(s)
Johnson & Johnson Surgical Vision Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →