Class II — Potential Health Hazard

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

Carl Zeiss Meditec AG Recalled by Carl Zeiss Meditec AG Due to Calibration setting was incorrectly entered during manufacturing causing...

Date: June 25, 2018
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

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

Quantity: 1

Why Was This Recalled?

Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

Where Was This Sold?

This product was distributed to 1 state: CA

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