Class II — Potential Health Hazard

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

Vision One Laser System Model GA-0025020 Recalled by Lumenis, Inc. Due to Lumenis has initiated a recall on certain models...

Date: August 19, 2013
Company: Lumenis, 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 Lumenis, Inc. directly.

Affected Products

Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

Quantity: 3 units

Why Was This Recalled?

Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

Where Was This Sold?

This product was distributed to 3 states: IL, NJ, PA

Affected (3 states)Not affected

About Lumenis, Inc.

Lumenis, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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