FDA-Device2018-11-21Class II
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.
Johnson & Johnson Surgical Vision Inc
Hazard
Expired intraocular lenses were distributed.
Sold states
US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
Affected count
17 IOL's
Manufactured in
1700 E Saint Andrew Pl, Santa Ana, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2019Don't want to check this manually?
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