Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

enVista one-piece hydrophobic acrylic toric intraocular lens Recalled by Bausch & Lomb Surgical, Inc. Due to The toric axis marks were misaligned (from the...

Date: June 9, 2020
Company: Bausch & Lomb Surgical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bausch & Lomb Surgical, Inc. directly.

Affected Products

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.

Quantity: 5

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bausch & Lomb Surgical, Inc.

Bausch & Lomb Surgical, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report