Class II — Potential Health Hazard

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

OptiMedica Catalys Precision Laser System Recalled by Abbott Medical Optics, Inc. Due to Device may experience loss of suction during treatment...

Date: February 20, 2015
Company: Abbott Medical Optics, 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 Abbott Medical Optics, Inc. directly.

Affected Products

OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

Quantity: 202

Why Was This Recalled?

Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Medical Optics, Inc.

Abbott Medical Optics, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

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