Class II — Potential Health Hazard

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

Treatment packs used on the VisuMax Laser Keratome. Size M Recalled by Carl Zeiss Meditec AG Due to Carl Zeiss Treatment pack, lot number M 130010,...

Date: February 3, 2014
Company: Carl Zeiss Meditec AG
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 Carl Zeiss Meditec AG directly.

Affected Products

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

Quantity: 1 package containing 10 individual treatment packs

Why Was This Recalled?

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

Where Was This Sold?

This product was distributed to 1 state: NV

Affected (1 state)Not affected

About Carl Zeiss Meditec AG

Carl Zeiss Meditec AG has 10 total recalls tracked by RecallDetector.

Related Recalls

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