Bausch & Lomb Surgical, Inc. recalls enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary…

Recall date

June 9, 2020

Source

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

Recall number

Z-2552-2020

FDA classification

Class II

Brand / firm

Bausch & Lomb Surgical, Inc.

Sold / distributed

U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.

Why it was recalled

The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

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

What was recalled

enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.