Bausch & Lomb Inc Irb recalls BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lens…

Recall date

September 3, 2015

Source

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

Recall number

Z-0206-2016

FDA classification

Class II

Brand / firm

Bausch & Lomb Inc Irb

Sold / distributed

Distributed US (nationwide), Canada, Japan and Thailand.

Why it was recalled

The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

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

What was recalled

BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.