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 Intraocular lens - Is indicated Recalled by Bausch & Lomb Surgical, Inc. Due to Cosmetic imperfections on the surface of some lenses.

Date: November 5, 2018
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 Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.

Quantity: 70,440 units

Why Was This Recalled?

Cosmetic imperfections on the surface of some lenses.

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