Johnson & Johnson Surgical Vision Inc recalls Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, R…

Recall date

June 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0464-2019

FDA classification

Class II

Brand / firm

Johnson & Johnson Surgical Vision Inc

Sold / distributed

US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.

Why it was recalled

Expired intraocular lenses were distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.