Class II — Potential Health Hazard

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

OCT-Camera 211 01 A3 Recalled by Haag-Streit USA Inc Due to Malfunction of the automatic laser beam shut-off, the...

Date: November 3, 2021
Company: Haag-Streit USA 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 Haag-Streit USA Inc directly.

Affected Products

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

Quantity: 3

Why Was This Recalled?

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Haag-Streit USA Inc

Haag-Streit USA Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

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