Class II — Potential Health Hazard

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

TECNIS Toric II OptiBlue IOL Models ZCW Recalled by Johnson & Johnson Surgical Vision, Inc. Due to Due to intraocular lens containing an angle out...

Date: December 12, 2023
Company: Johnson & Johnson Surgical Vision, Inc.
Status: Ongoing
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 Johnson & Johnson Surgical Vision, Inc. directly.

Affected Products

TECNIS Toric II OptiBlue IOL Models ZCW

Quantity: 36

Why Was This Recalled?

Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.

Where Was This Sold?

International distribution to the country of Japan.

About Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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