Class II — Potential Health Hazard

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

Bausch + Lomb Stellaris PC Vision Enhancement System Recalled by Bausch & Lomb Inc Due to Posterior fluidics modules installed in the system may...

Date: August 31, 2012
Company: Bausch & Lomb 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 Bausch & Lomb Inc directly.

Affected Products

Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.

Quantity: 124 units

Why Was This Recalled?

Posterior fluidics modules installed in the system may need to be recalibrated.

Where Was This Sold?

Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon. There was no government or military distribution.

About Bausch & Lomb Inc

Bausch & Lomb Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

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